Health Pregnancy, Healthy Baby:  Testing the added benefits of pregnancy ultrasound for child development in a randomised control trial

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Prior research indicates that ultrasound can also increase parental-fetal attachment. We aim to establish whether, compared to routine care, messages to promote parental attachment and healthy child development, conducted during one or two pregnancy ultrasounds improve early child development and growth, exclusive breastfeeding, parental-child interactions and pre- and post-natal clinic attendance. Methods The effect of messages to sensitise mothers and fathers to fetal development will be tested in a 3-armed randomised trial with 100 mothers and their partners from Soweto-Johannesburg in each arm. The primary outcome is child development at 6 months post-natal. Secondary outcomes include infant feeding, parental attachment and interaction, parental mental health and infant growth, assessed at 6 weeks and 6 months. Parents in Arm 1 receive a fetal ultrasound <25 weeks during routine antenatal care at tertiary hospitals, and a second standard ultrasound at the research site within 2 weeks. Arm 2 participants receive the routine antenatal ultrasound and an additional ultrasound <25 weeks at the research site, together with messages to promote parental attachment and healthy child development. Arm 3 participants receive the routine ultrasound and two additional ultrasounds at the research site, <25 weeks and <36 weeks, together with messages to promote parental attachment and healthy child development. Discussion Evidence from high-income countries suggests that first-time prospective mothers and fathers enjoy seeing their fetus during ultrasound and that it is an emotional experience. A number of studies have found that ultrasound increases maternal attachment during pregnancy, a predictor of positive parent-infant interactions which, in turn, promotes healthy infant development. It is generally agreed that studies are needed which follow up parental-child behaviour and healthy child development postnatally, include fathers, and examine the construct in a wider diversity of settings, especially in low- and middle-income countries. Testing the added benefits of pregnancy ultrasound for child development is a gap that the proposed trial in South Africa seeks to address. Trial Registration The trial is registered with the Pan African Clinical Trials Registry (https://pactr.samrc.ac.za) on 15 August 2018 (identifier: PACTR201808107241133). Integrative & Complementary Medicine Internal Medicine Translational Medicine Fetal ultrasound Antenatal attachment Early childhood development Mother-child interaction Growth Pregnancy/antenatal Background More than 250 million children younger than 5 years in low- and middle-income countries (43% of the total globally) are at risk of not reaching their developmental potential because they are stunted or live in extreme poverty. This rises to 70% of young children in Sub-Saharan Africa, which has the highest risk burden in the world (1). In South Africa (SA), the risk is 39% of children under 5 years of age, with knock-on losses of human capital due to inadequate school learning and low earning capacity (2). The Global Strategy for Women’s, Children’s and Adolescents’ Health (3), and the fourth Sustainable Development Goal (4) recognise the importance of promoting early childhood development (ECD) to ensure that children survive and thrive, and rightfully fulfil their human potential and contribute productively to their families and societies. The 2017 Lancet Series Advancing Early Childhood Development: From Science to Scale, recommended that the contacts which the Reproductive, Maternal, Newborn and Child Health (RMNCH) services have with pregnant women, parents and families are important entry points to promote ECD (5). Further, it noted that many effective programmes for ECD are currently built on health services, demonstrating the feasibility of this approach for taking interventions to promote ECD to scale (2, 6). In 2015, South Africa adopted a National Integrated Early Childhood Development Policy that mandates the health sector to lead in providing services for children and families in the first 1000 days of life, starting from conception, in collaboration with other relevant sectors. Taking this up, the National Department of Health (NDoH) launched a Side-by-Side campaign (7) to bolster support for pregnant women and families with young children, and revised the Road to Health Booklet to emphasise survive and thrive. The 2015 NDoH Guidelines for Maternity Care in SA (8), recommend that all pregnant women attending a district hospital should have access to one ultrasound scan (US) 18–20 weeks gestation. The purpose of the US is to confirm an intra-uterine pregnancy, fetal viability, the number of fetuses, gestational age, location of the placenta and amniotic fluid volume. The 2016 WHO Antenatal Guidelines (9) recommend one US before 24 weeks gestation “to estimate gestational age, improve detection of fetal abnormalities and multiple pregnancies, reduce induction for post-term pregnancy, and improve a women’s pregnancy experience” (Recommendation B.2.4). Taking advantage of the SA and WHO recommendations that pregnant women have an ultrasound examination before 24 weeks gestation, the aim of this three-arm trial is to assess whether messages to promote ECD delivered during pregnancy and one or two additional ultrasound examinations will increase parental investment in ECD as indexed by infant development, nutrition and growth, and the quality of parent-child relationships 6 weeks and 6 months post-partum. Benefits of pregnancy ultrasound In addition to the survival and health benefits of US reviewed by WHO in preparation of the guidelines (10), the possibility is raised that US may increase antenatal clinic (ANC) use (11), particularly in view of the recommendation that ANC visits be increased from four to eight. However, the evidence on ultrasound, including any psychological benefits, is derived almost solely from high-income countries (HIC). Early pregnancy US have been routine in HICs for more than 30 years. At the time of introduction of US, studies reported positive parental reactions to seeing images of the fetus (12, 13), that parents enjoyed the experience and that they found it useful to receive information during US (14). Reading et al (15) commented on the potential of US to change parental behaviour for the better, such as smoking cessation during pregnancy. Rothenberg speculated that further research could “lead to the development of ultrasound use patterns designed to enhance maternal attachment”, and that “the psychosocial dimension of ultrasound scanning seems obvious to patients and personnel in the field” (16 p171). In qualitative studies, both mothers and fathers report enjoying the US experience and that the presence of the father seemed to have a beneficial effect on the mother (17). A 1999 review concluded that there was as yet no evidence of increases in health behaviours following US nor that ‘seeing the baby’ stimulates parental-fetal attachment (18). Based on their review, Baillie et al cautioned that “Practitioners and decision makers should be wary of over-interpreting enjoyment of a procedure as evidence of its therapeutic power” (18 p149). Later studies however report positive effects of US on maternal and paternal attachment (19–22) but only a few have examined the effects of US on attachment after birth (23, 24). US studies conducted in sub-Saharan Africa have principally focused on US costs, maintenance, training, human resources, acceptability, and other aspects of feasibility, including in Ghana (25), Kenya (26), Malawi (27), Nigeria (28–30), Rwanda (31) South Africa (32), Tanzania (33, 34) and Uganda (35, 36). In general US is thought to enhance antenatal care through confirmation of pregnancy status and more accurate estimation of gestational age, but concerns remain about feasibility of wide-scale use in low and middle-income countries and the potential misuse of US for sex determination in countries with high preference for male children (37). A recent large cluster-randomised control trial in Pakistan, Kenya, Zambia, DRC and Guatemala suggested that US did not increase ANC use or hospital births (38). However, a review in Sub-Saharan Africa concluded that “The potential benefits of obstetric ultrasound are yet to be fully realized in SSA due to challenges ranging from individual patients to institutional and national policies. While there may be conflicting evidence on the impact of universal access on perinatal outcomes, the region presents many research opportunities that could provide answers to these questions” (39 pE58). Point of Care Ultrasound (PoCUS) makes scale-up more feasible (39, 40) and evidence with its use more positive than standard US. A recent review (41) concluded that in every study in which it was examined in LMICs, PoCUS increased antenatal clinic attendance and assisted with the identification and treatment of conditions associated with maternal and neonatal morbidity in under-resourced settings. PoCUS thus has the potential to bring much-needed services to women in rural communities and in poor countries, many of whom need these services most. In addition to increasing access to services, US has also been found to provide an opportunity to engage fathers (42), with the potential of garnering support for the expectant mother and their child and potential sharing of childcare responsibilities. This study examines US augmented with messages about foetal and infant development and the importance of parent wellbeing and infant care on postnatal care and early childhood development. We hypothesise that one or two US with messages about fetal and infant development will have a positive effect on infant development at 6 months post-natal, as well as on parental wellbeing, parent-child attachment, infant feeding and growth and use of preventive health care services. Methods Objectives The trial will evaluate the potential benefits of US on early childhood development and child care by augmenting a routine antenatal service currently provided mainly in tertiary public health facilities in South Africa, with plans to be rolled out to district hospitals. The goal of the intervention is to increase parental investment not only in child survival, but also for the wellbeing and healthy growth and development of their child. We aim to establish whether, compared to routine care, messages about fetal and child development delivered during one (<25 weeks) or two (< 25 weeks and again <36 weeks) fetal ultrasounds improve ECD and growth, exclusive breastfeeding, mother/father-infant attachment, maternal and paternal well-being, father involvement and pre- and post-natal clinic attendance. Specific objectives are to evaluate whether child development messages delivered during one or two ultrasounds: Improve early child development Improve infant breastfeeding practices and healthy child growth Improve parent-infant attachment and interaction during pregnancy and six months after birth Increase paternal engagement in a young child’s development and care Design Eligible mothers will be randomised to one of three arms. Arm 1, the control group, will receive standard practice of care during pregnancy; arm 2 will receive the child development intervention at the first research ultrasound visit, and arm 3 will receive the intervention at two research ultrasound visits. All mothers, infants and partners (where available) will be followed-up 6 weeks and 6 months postnatally for assessments. Participants will continue to receive routine ante-, peri- and postnatal care as provided by the tertiary care facility from which all participants are being recruited from. Setting The study is situated in Soweto, South Africa. Soweto is adjacent to Johannesburg and is the most populous Black urban residential area in South Africa with over 1.3 million people counted in the most recent census (43). Participants will be recruited from women attending antenatal care at Chris Hani-Baragwanath Academic Hospital (CHBH), a tertiary teaching hospital that attends to over 22,000 births annually. Women are referred to CHBH from community health centres with risk factors including HIV and hypertension. Recruited women will attend their study ultrasound visits at the SAMRC Development Pathways for Health Research Unit (DPHRU), which is located on the grounds of CHBH and in walking distance of the CHBH antenatal services. Procedures Recruitment Approximately 500 women present to CHBH each month for their first pregnancy ultrasound, of which, 50 percent are <25 weeks gestation. This offers a potential pool of 250 women a month to be included in the study. Participants will be recruited from women attending the Foetal Medicine Unit (FMU) at CHBH, where routine fetal ultrasounds are conducted. Eligible women will be resident within Soweto, 18 years and older, with a singleton pregnancy and presenting <25 weeks gestation. Major fetal abnormalities detected during the first routine ultrasound conducted by an experienced radiologist in the FMU, or severe maternal morbidities, will exclude a pregnant woman from the trial. These women will be transferred to specialised clinical services at CHBH where she will receive appropriate treatment. Sample size calculations were based on detecting a 0.5 standard deviation (SD) difference between arms on both the Bayley III Language and Cognitive Scales, and z-scores for weight-for-age (WAZ), length-for-age (LAZ) and weight-for-length (WLZ) measured at 6 months of age at 90% power, which is 85 per arm. Allowing for 15% potential attrition during pregnancy and during follow-up to six months of infant age, sample size in each of the three arms will be 100. This makes a total sample size of 300 women for recruitment. Intervention Women will be randomised to one of three arms on recruitment at CHBH <25 weeks gestation after having a fetal ultrasound as part of routine antenatal hospital services. The women will be blind to their arm allocation and remain blinded until study completion. Using computer-generated simple randomisation, each consecutive woman screened will be randomly allocated to a study arm. Research assistants responsible for screening will receive the study arm numbers for allocation from the study coordinator on a daily basis. The allocation sequence will be concealed from the research assistants enrolling the participants. Women recruited for arm 1 will act as the control group and will receive one further standard US at DPHRU <25 weeks gestation when they will receive standard fetal growth measurements, but no child development messages. In addition to their routine antenatal US at CHBH, women recruited to arm 2 will receive an additional US <25 weeks gestation at DPHRU, during which they will receive messages to promote early childhood development. During the US session, the sonographer will talk with the mother and partner, if present, about the fetus’ sensory development and capacity for learning, fetal responsivity to the environment, maternal wellbeing and the dependence of the fetus on maternal and paternal health and wellbeing before and after birth. In addition to their routine antenatal US at CHBH, women recruited to arm 3 will receive two additional USs at DPHRU, one <25 weeks gestation (early US) and another < 36 weeks gestation (late US). They will receive the same child development messages as mothers in arm 2 at the first US. During the second US, in addition to childhood development messages, the sonographer will encourage the woman and her partner, if present, to personalise the baby, strengthen intentions to exclusively breastfeed, talk and sing to the child before and after birth, and counsel them on how to respond to their young infants emotional and learning needs. Partner involvement and interest in the baby is encouraged by inviting partners to attend the ultrasound sessions of women in all three arms. For mothers recruited to arms 2 and 3, digital ultrasound images and a photograph of the woman (with her partner where present) having the US will be sent to parents via WhatsApp and printed images given to the parents. A small baby book with the child development messages, as appropriate to the arm, is given to the mothers in arms 2 and 3, and they are encouraged to paste the printed pictures into the book and to share the US images and photographs with family and friends. Two qualified and registered sonographers will be trained to deliver the intervention and a Philips HD9 Ultrasound System will be used to conduct all ultrasounds. Due to the nature of the intervention, the sonographers will not be blind to the mother arm allocation. Data collection Study data will be collected and managed using REDCap (Research Electronic Data Capture) hosted by the University of the Witwatersrand. Data will be collected on the enrolled women, child and partners (where appropriate) at three stages; 1) baseline at first research ultrasound at DPHRU <25 weeks; 2) 6-week post-natal follow-up, and 3) 6-month post-natal follow-up. Data will be collected on tablets at stages one and two by two trained data collectors under the supervision of the study coordinator. At stage three, data will be collected by occupational therapists or physiotherapists trained in administering child development measures, under the supervision of the study coordinator. All data collectors will be trained on the principles of research ethics, good clinical practice, referral procedures and management of difficult situations in the field. Table 1 shows the schedule of enrolment, interventions and data collection. [Table 1 placed here] The data collected at each stage is as follows: Baseline at first research ultrasound at DPHRU. Data at the first research visit (<25weeks) will include participant contact details, demographic characteristics and reproductive history, socio-economic status, social and instrumental support, and breastfeeding intentions. Maternal and paternal fetal attachment is assessed using the Maternal and Paternal Attachment Scales (44, 45), and the mother and her partner, if available, will complete a social support questionnaire and the Edinburgh Postnatal Depression Scale (46). The woman and her partner, if available, will also be asked to complete an ultrasound experience questionnaire after the US. Six week postnatal follow-up. Two trained outcome assessors, blind to the mother’s arm allocation, will complete the follow-up questionnaires with the mothers, infants and partners, where available. Questionnaires will assess perinatal and postnatal information, breastfeeding practices and partner and social support. Postnatal depression will be assessed for the mother and partner using the Edinburgh Postnatal Depression Scale. Infant growth will be assessed using standard procedures for infant weight and length (the SECA 416 infantometer for length and the SECA 367 infant scale for weight). Measures will be converted to z-scores using the 2006 WHO Growth Standards for LAZ, WAZ and WLZ. Birth weight and length as well as key information on maternal and infant birth outcomes will be collected from the infant’s Road to Health Booklet. Six month postnatal follow-up. Occupational therapists or physiotherapists trained in child development will complete the six-month follow-up assessments with the mothers, infants and partners, where available. The primary outcome for the six-month follow-up is child development as measured by the Bayley Scales of Infant and Toddler Development, Third edition (47). All the study outcome measures are shown in Table 2. [Table 2 placed here] Formative and process data Study procedures were informed by formative qualitative research conducted with pregnant women attending antenatal care at CHBH prior to the trial inception. We have written standard operating procedures (SOPs) to support the research team to deliver the study procedures and intervention according to the protocol. Participant adherence will be assessed by counts (for example, visit attendance) and intervention delivery will be monitored by observing contacts between the sonographer (who will conduct the ultrasound and deliver the ECD messages) and participants (intervention and control) to record the nature of interactions. We will monitor intervention dose and experience by recording the duration of the ultrasound visit (with and without delivery of the intervention) and by gathering participant and partner views on the ultrasound experience. Ongoing consultation with a key stakeholder network will inform intervention procedures and assist with contextualising the intervention and addressing any challenges that may arise during trial implementation. Due to the well-documented challenges with engaging men in research and health care in South Africa, (54) we will adopt pro-active recruitment strategies, which will include phone calls to partners after participant enrolment and follow-up calls closer to the visit to encourage attendance. We have also included Saturday sessions for those partners who are unable to attend during the week due to work commitments. Research staff will make regular contact with participants in-between study visits to maintain accuracy of records and to promote retention of participants in the study. We will follow up participants who default and those who withdraw to gain an understanding of why they dropped out during the course of the trial. Data analysis All available data at baseline will be analysed descriptively for each intervention group and in total. Categorical data will be summarised by numbers and percentages. Continuous data will be summarised by mean, SD and range if data are normal and median, IQR and range if data are skewed. Minimum and maximum values will also be presented for continuous data. Differences regarding baseline variables will be checked for clinical relevance between the three treatment groups. A CONSORT flow diagram will be used to summarise the number of participants who were: assessed for eligibility at screening, were eligible at screening, eligible and randomised, lost to or discontinued the intervention, included in the primary outcome analysis. If possible respondents and non-respondents will be compared. The analysis of the primary outcome will be performed on the intention to treat population with no imputation of missing data. In the primary analysis, child development scores will be compared to the control group. If outcome data are normally distributed, we will fit linear regression models. If not normally distributed, outcome data will be categorised and logistic regression methods will be used to assess differences between intervention and control groups. Tests will be two-sided with a significance level of 0.05 and 95% Confidence Intervals will also be reported. In case of relevant differences in baseline characteristics additional adjustment(s) for these factors will be performed within the models to address potential confounding. A stratified analysis will be done for three pair-wise comparisons, i.e. Arm 1 vs. control, Arm 2 vs. control, Arm 1 vs. Arm 2 (as described in 6.2 ) according to the following subgroups: Partner vs no partner accompaniment and parity. STATA, Version 15 (StataCorp, College Station, Texas, USA) will be used for all analyses. Missing data and data from those who withdraw from the study will not be interpreted. Discussion While ultrasound has long been regarded as having potential to be transformative and to improve parental behaviour (14) as well as commitment to the growing child (12), this hypothesis has only been tested in a few studies in high-income countries, fewer of which were randomised control trials (55). There is clear evidence from high-income countries that the first time a prospective mother sees an image of their fetus during ultrasound is an emotionally enjoyable experience, which parents report intensifies their attachment to the coming baby. This is true also of prospective fathers (22, 56), and is reported as being an important bonding experience for the family (57). A number of studies have examined the impact of ultrasound on maternal attachment (24, 58, 59). However, women’s experiences of ultrasound are dependent on the context and the behaviour of the sonographer, with some women reporting feeling objectified and poorly informed during the experience (60). Research on the emotional and relationship effects of early ultrasound are important because maternal (and presumably paternal) representations of the coming baby are significant predictors of parent-infant interactions which, in turn, affect healthy infant development (61, 62). A recent review of interventions indicated that awareness programmes, most commonly involving pregnancy ultrasound, were amongst the most promising interventions to increase parent-fetal attachment (55). There is agreement that studies are needed which follow up parental-child behaviour and healthy child development post-natally, include fathers, and examine the construct in a wider diversity of settings, including in low- and middle-income countries. Testing the added benefits of pregnancy ultrasound for child development is the gap that the proposed randomised control trial in South Africa seeks to address. Should this trial demonstrate feasibility and improvement in the specified intermediate and outcome measures, the next step would be a pragmatic trial situated in the health care system, with longer-term outcomes and cost-effectiveness estimations. Dissemination policy We will share the study results with the trial stakeholder network, including the study participants (where requested), the South African Ministry of Health and relevant clinical, academic and research partners. We will also publish the results after study completion. Authorship will include the co-investigators as well as any post-gradaute students who may contribute substantially to analysis and writing of a particular paper. Professional writers will not be used. Trial status The trial protocol, version number 2.0, was approved on 16 January 2019 and is ongoing. The recruitment began on 1March 2019 and was completed on 30 September 2019. Trial procedures are expected to be complete by the end of July 2020. Abbreviations ANCAntenatal clinic BayleyIIIBayley Scales of Infant and Toddler Development, Third Edition CHBHChris Hani-Baragwanath Hospital DPHRUDevelopmental Pathways to Health Research Unit ECDEarly childhood development FMUFoetal Medicine Unit HICHigh income country NDoHNational Department of Health SASouth Africa USUltrasound WHOWorld Health Organization Declarations Ethics approval and consent to participate The study has been approved by the Human Research Ethics Committee (Medical) of the University of the Witwatersrand, South Africa (M181915) and the Medical Advisory Committee of CHBH who oversee adherence to the study protocol. Both mothers and fathers provide written informed consent. The participants provide written consent for the publication of group results from the study. Participants will be given a numerical identifier and all personal information will remain confidential. Because the participants are initially screened through the Foetal Medicine Unit at CHBH, the study team envisage minimal risk to the pregnant women (or foetuses) and infants. However, any indications of negative effects or complications will be actioned swiftly. If it is thought that the woman or her baby may have a health problem (physical or mental) or if any changes or abnormalities are detected at a study visit, the participants will be referred to a trained nurse at the DPHRU research site who will make further enquiries, provide participants and facilitate the necessary referrals to CHBH departments. A senior clinician from CHBH is included in the investigator team and theywho will assist in ensuring swift referral, management and follow up of women enrolled in the study at the hospital. Women or their partners requiring psychological support will be referred to an onsite professional nurse at the research site for further assessment and counselling. There is an established network of referral bodies within the public health sector and supporting NGOs for further management. Research staff will enquire about any incidents or changes since a participant’s last visit and these will be documented and actioned, if needed. Any adverse effects as a result of the trial will be reported to the ethical committee, and participants will be referred to the clinical services provided at CHBH. Any modifications to the protocol will be communicated to the funders and the ethical committees. In addition, the Trial Advisory Committee for this study consists of leading international researchers and clinicians in the fields of maternal and child health, as well as mental health, who will play a direct role in the oversight and monitoring of the study procedures and progress. Consent for Publication Not Applicable Availability of data and materials The questionnaires and coding sheets used in the study, as well as anonymised data, will be included in or as supplementary files to articles published, as required. Trial results will be disseminated to participants and relevant health care providers via a stakeholder committee. Competing interests Each of the authors declare that they have no competing interests Funding This project is supported by Saving Brains. Saving Brains is a partnership of Grand Challenges Canada, the Aga Khan Foundation Canada, the Bernard van Leer Foundation, the Bill & Melinda Gates Foundation, The ELMA Foundation, Grand Challenges Ethiopia, the Maria Cecilia Souto Vidigal Foundation, the Palix Foundation, the UBS Optimus Foundation and World Vision Canada (SB-POC–1810–19664). The funders have no role in study design, data collection, management and analysis. The authors are responsible for the monitoring of data and act independently from the funders. Authors’ contributions LMR wrote the paper. WS, SAN, AS, LP and DP made substantial contributions and approved the final version for publication Acknowledgements Wihan Taljaard, Lukhanyo Nyati and Roisin Drysdale provided research support. References Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, et al. Early childhood development coming of age: science through the life course. Lancet. 2017;389:77–90. Richter LM, Daelmans B, Lombardi J, Heymann J, Boo FL, Behrman JR, et al. Investing in the foundation of sustainable development: pathways to scale up for early childhood development. Lancet. 2017;389:103–18. Every Women Every Child. The Global Strategy for Women’s, Children’s and Adolesents’ Health (2016–2030). 2016. https://www.who.int/life-course/partners/global-strategy/globalstrategyreport2016–2030-lowres.pdf. Accessed 13 Aug 2019. 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Awareness of information, expectations and experiences among women for obstetric sonography in a south east Nigeria population. East Afr J Public Health. 2011;8:142–4. Shah SP, Epino H, Bukhman G, Umulisa I, Dushimiyimana, JMV, Reichman A, et al. Impact of the introduction of ultrasound services in a limited resource setting: rural Rwanda 2008. BMC Int Health Hum Rights. 2009;9:4. Geerts LTB, Esther J, Theron GB. Routine obstetric ultrasound examinations in South Africa: cost and effect on perinatal outcome–a prospective randomised controlled trial. BJOG. 1996;103:501–7. Åhman A, Kidanto HL, Ngarina M, Edvardsson K, Small R; Mogren I. ‘Essential but not always available when needed’–an interview study of physicians’ experiences and views regarding use of obstetric ultrasound in Tanzania. Glob Health Action. 2016;9:31062. Firtha ER, Mlay P, Walker R, Sill PR. Pregnant women’s beliefs, expectations and experiences of antenatal ultrasound in Northern Tanzania. Afr J Reprod Health. 2011;15. Gonzaga MA, Kiguli-Malwadde E, Businge F, Byanyima R. Current knowledge, attitudes and practices of expectant women toward routine sonography in pregnancy at Naguru health centre, Uganda. Pan Afr Med J. 2009;3. Mabuuke AG, Kiguli-Malwagge E, Businge F, Byanyima RK. Utilisation of obstetric sonography at a peri-urban health centre in Uganda. Pan Afr Med J. 2010;7. Kim ET, Singh K, Moran A, Armbruster D, Kozuki N. Obstetric ultrasound use in low and middle income countries: a narrative review. Reprod Health. 2018;15:129. McClure E, Goldenberg R, Swanson D, Saleem S, Esamai F, Garces A, et al. 3: Routine antenatal ultrasound in low/middle income countries: a cluster randomized trial. Am J Obst Gynecol. 2017;216:S3. Wanyonyi SZ, Mariara CM, Vinayak S, Stones W. Opportunities and Challenges in Realizing Universal Access to Obstetric Ultrasound in Sub-Saharan Africa. Ultrasound Int Open. 2017;3:E52–9. Harris RDM, William M. Compact Ultrasound for Improving Maternal and Perinatal Care in Low‐Resource Settings. J Ultrasound Med. 2009;28:1067–76. Doig M, Dizon J, Guerrero K, Parange N. Exploring the availability and impact of antenatal point-of-care ultrasound services in rural and remote communities: A scoping review. Australas J Ultrasound Med. 2019. Walsh TB, Tolman RM, Singh V, Davis MM, Davis RN. Expectant fathers’ presence at prenatal ultrasounds: An opportunity for engagement. Soc Work Res. 2017;41:181–5. Statistics South Africa. http://www.statssa.gov.za/. Accessed 12 Aug 2019. Condon JT. The assessment of antenatal emotional attachment: Development of a questionnaire instrument. Br J Med Psychol. 1993;66:167–83. Condon JT, Boyce P, Corkindale CJ. The First-Time Fathers Study: a prospective study of the mental health and wellbeing of men during the transition to parenthood. Aust N Z J Psychiatry. 2004;38:56–64. Cox DN, Wittman BK, Hess M, Ross AG, Lind J, Lindahl S. The psychological impact of diagnostic ultrasound. Obstet Gynecol. 1987;70:673–6. Bayley N. Bayley scales of infant and toddler development: Bayley-III. San Antonio, Texas: Harcourt Assessment 2006. Ballot DE, Ramdin T, Rakotsoane D, Agaba F, Davies VA, Chirwa T, Cooper PA. Use of the Baley scales of infant and toddler development, third edition, to assess developmental outcomes in infants and young children in an urban setting in South Africa. Int Sch Res Notices. 2017;2017:1631760. Frankenburg WK, Coons CE. Home screening questionnaire: its validity in assessing home environment. J Pediatr. 1986;108:624–6. Grieve KW, Richter LM. A factor analysis study of the home screening questionnaire for infants. S Afr J Psychol. 1989;20:277–81. Richter LM, Grieve KW, Austin D. Scaffolding by Bantu mothers during object play with their infants. Early Child Dev Care. 1988:34. Lawrie TA, Hofmeyr GJ, de Jager M, Berk M. Validation of the Eginburgh Postnatal Depression Scale on a cohort of South African women. S Afr Med J. 1998;88:1340–4. Ven Heyningen T, Honikman S, Tomlinson M, Field S, Myer L. Comparison of mental health screening tools for detecting antenatal depression and anxiety disordersin South African women. PLoS One. 2018;13. Makusha T, Richter LM. Father involvment in the first 1,000 days. In: van den Berg W, Makusha T, editors. State of South Africa’s fathers 2018. Cape Town: Sonke Gender Justice and Human Sciences Research Council; 2018. p. 49–64. Cunen NB, Jomeen J, Xuereb RB, Poat A. A narrative review of interventions addressing the parental–fetal relationship. Women Birth. 2017;30:e141–51. Draper J. ‘It’s the first scientific evidence’: men’s experience of pregnancy confirmation. J Adv Nurs. 2002;39:563–70. Ekelin M, Crang-Svalenius E, Dykes AK. A qualitative study of mothers’ and fathers’ experiences of routine ultrasound examination in Sweden. Midwifery. 2004;20:335–44. Alhusen JL. A literature update on maternal‐fetal attachment. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2008;37:315–28. Cannella BL. Maternal–fetal attachment: an integrative review. J Adv Nurs. 2005;50:60–8. Van der Zalm JE, Byrne PJ. Seeing baby: women’s experience of prenatal ultrasound examination and unexpected fetal diagnosis. J Perinatol. 2006;26(7):403. Barlow J. The relationship with the unborn baby: Why it matters? Int J Birth Parent Educ. 2016;4:5. Cataudella S, Lampis J, Busonera A, Marino L, Zavattini GC. From parental-fetal attachment to a parent-infant relationship: a systematic review about prenatal protective and risk factors. Life Span and Disability. 2016;19:185–219. Tables Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) showing the schedule of enrolment, interventions and data collection STUDY PERIOD Enrolment Intervention Follow-up TIMEPOINT <22 weeks GA <25 weeks GA <36 weeks GA 6 weeks postnatal 6 months postnatal ENROLMENT: Eligibility screen X Informed consent X Random allocation X INTERVENTIONS: Early US X Early US with messages X Early and late US with messages X X ASSESSMENTS: BASELINE AND ANTENATAL Socio-demographic questionnaire X Fetal growth assessment X X Social support X X Maternal and Paternal antenatal depression and anxiety X X Maternal and Paternal antenatal attachment X X Maternal and paternal antenatal depression X X US experiences questionnaire X X OUTCOMES: PRIMARY AND SECONDARY Bayley Scales of Infant and Toddler Development (3 rd edition) X Home Screening Questionnaire X Mother/father-infant interaction X Perinatal and postnatal information X Infant behaviour (crying, sleeping etc.) X Breastfeeding practices questionnaire X X Maternal and paternal postnatal depression and anxiety X X Social support X X Partner involvement X X Infant growth – weight and length X X Immunisation status X X Clinic attendance X X Table 2 Study Outcome Measures OUTCOME INSTRUMENT MEASURE DESCRIPTION METHOD OF AGGREGATION TIMEPOINT Primary outcome Child development at 6 months Bayley Scales of Infant and Toddler Development (3 rd edition) (Bayley III) The total score from each developmental domain The Bayley III is an individually administered assessment of a child’s attainment of developmental milestones across five domains, i.e. cognitive, language, motor, social-emotional and adaptive skills (47). It has been recognised internationally as the most comprehensive tool to assess children from as young as one month old and has been validated in South Africa (48) Individual scores to be compared between intervention and control groups using linear or logistic regression models dependant on the distribution of the data. End point Home Screening Questionnaire (HSQ) HSQ score The Home Screening Questionnaire (HSQ), a 30-item parent-report tool, used to identify features of the home environments related to childhood development (49). The HSQ has been validated and used for research purposes in a number of countries, including South Africa (50). Individual scores to be compared between intervention and control groups using linear or logistic regression models dependant on the distribution of the data. End point Secondary outcomes Mother/father-infant interaction at 6 months Mother/father interaction rating scale Interaction score Rated from a 5-minute videotape of mother/father and infant “talking and playing with each other” with the infant in a high chair, mother sitting on a chair at the same height opposite the infant and an attractive stack toy for them to share. We will use an adapted coding schemes developed by Richter to code engagement (eye contact, joint attention), emotional tone, emotional regulation (maternal/paternal comforting for distress), maternal/paternal responsiveness, and maternal/paternal scaffolding (51). Individual scores to be compared between intervention and control groups using linear or logistic regression models dependant on the distribution of the data. End point Infant growth at 6 weeks and 6 months Weight and length Weight (grams) Length (cms) Weight-for-age z-score (WAZ) Length-for-age z-score (LAZ) Weight-for-length z-score (WLZ) Infant growth will be measured using standard procedures for infant weight and length, and converted to z-scores using the 2006 WHO Growth Standards (WAZ, LAZ and WLZ). Differences in mean weight and length of infants will be compared between intervention and control groups Intermediate and end point Breastfeeding practices at 6 weeks and 6 months Maternal self-report questionnaire Breastfeeding initiation and duration Information on breastfeeding practices will be collected by trained interviewers using a semi-structured questionnaire. Categorical data will be presented as numbers and percentages. Changes in breastfeeding practices will be compared between intervention and control groups. Intermediate and end point Maternal and paternal postnatal depression and anxiety during pregnancy, at 6 weeks and 6 months Edinburgh Postnatal Depression Scale (EPDS) EPDS score The EPDS is a screening tool for antenatal and postnatal depressive symptoms among women. The EPDS has been validated for use antenatally and postnatally in a number of settings, including South Africa (52, 53). Proportion of mothers/partners showing signs indicative of depression will be compared during pregnancy, 6 weeks and 6 months. Data will be summarised by mean, SD and range at each time point. Baseline, intermediate and end point Immunisation status and clinic attendance at 6 weeks and 6 months Road to Health Booklet (child health record) or maternal/paternal self-report Clinic attendance at routine child services (immunisation, growth monitoring, developmental screening, Vitamin A, deworming). Other health contacts (e.g. sick child care) Categorical data will be presented as numbers and percentages with comparisons in proportions made at 6 weeks and 6 months. Intermediate and end point Partner involvement during pregnancy, at 6 weeks and 6 months Maternal/paternal self-report Partner involvement in child care Information on partner involvement in child care will be collected by trained interviewers using a semi-structured questionnaire. Categorical data will be presented as numbers and percentages with comparisons in proportions made at 6 weeks and 6 months. Baseline, intermediate and end point Supplementary Files SPIRITFillablechecklist.doc Cite Share Download PDF Status: Published Journal Publication published 06 Jan, 2020 Read the published version in Trials → Version 3 posted Editorial decision: Accept 21 Nov, 2019 Editor assigned by journal 20 Nov, 2019 Submission checks completed at journal 19 Nov, 2019 You are reading this latest preprint version Show more versions Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4014","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":223841,"identity":"23dc00da-eb76-49ed-a6f2-dd650b95548d","order_by":1,"name":"Linda Marlene Richter","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAUlEQVRIie3PsUrDQBzH8V8IJMtfs15owFe4UBCKyL1KQqDPEEFKsnQKZC1UfIzOLQed4h7RRbp2qFtEUf9pXQSTdnS473BcIB/+9wdMpn+YtAEBfFJ7AinoVKKZ8A0V6KiROBDsiTXF8THSPVvVDXTgzcvV5uZeB8pbWrsGk4vuh50no4J3Ec/aDh8WmkhEtl/ACbNOQpeC0JAUiePniycmwIDfZ/UR/wNVS9y3/I6Jt7TfeTXVRwaE9X6KlWdMEDk8RcY9ZHgVSE2iToZ+tv4iquPpqJBR0kVUWYWP21Qrbxa/vGa3Y+WWWtdNOrnuIj+zfn21i8u/fzSZTCbTaX0Dn75H6gv2sSEAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-3654-3192","institution":"University of the Witwatersrand","correspondingAuthor":true,"prefix":"","firstName":"Linda","middleName":"Marlene","lastName":"Richter","suffix":""},{"id":223842,"identity":"eabbfa38-6b8e-482c-886f-6892006b9830","order_by":2,"name":"Wiedaad Slemming","email":"","orcid":"","institution":"University of the Witwatersrand","correspondingAuthor":false,"prefix":"","firstName":"Wiedaad","middleName":"","lastName":"Slemming","suffix":""},{"id":223843,"identity":"e9327b5b-4e2f-4be3-8c03-1c201a32ebba","order_by":3,"name":"Shane A Norris","email":"","orcid":"","institution":"University of the Witwatersrand","correspondingAuthor":false,"prefix":"","firstName":"Shane","middleName":"A","lastName":"Norris","suffix":""},{"id":223844,"identity":"997119c0-834e-4ed6-97b0-9a9fe4b8f3d5","order_by":4,"name":"Alan Stein","email":"","orcid":"","institution":"University of Oxford","correspondingAuthor":false,"prefix":"","firstName":"Alan","middleName":"","lastName":"Stein","suffix":""},{"id":223845,"identity":"02cfa28b-f0f4-46ee-b516-91e913e21cdc","order_by":5,"name":"Lucilla Poston","email":"","orcid":"","institution":"King's College London","correspondingAuthor":false,"prefix":"","firstName":"Lucilla","middleName":"","lastName":"Poston","suffix":""},{"id":223846,"identity":"383387f6-3ddc-453b-b60c-ac0d451a63e8","order_by":6,"name":"Dharmintra Pasupathy","email":"","orcid":"","institution":"King's College London","correspondingAuthor":false,"prefix":"","firstName":"Dharmintra","middleName":"","lastName":"Pasupathy","suffix":""}],"badges":[],"createdAt":"2019-08-18 12:23:21","currentVersionCode":3,"declarations":"","doi":"10.21203/rs.2.13300/v3","doiUrl":"https://doi.org/10.21203/rs.2.13300/v3","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-019-3924-0","type":"published","date":"2020-01-06T12:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":13480143,"identity":"c03bcc35-f190-4d63-a552-ed8b825e157a","added_by":"auto","created_at":"2021-09-16 21:42:02","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":401931,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4014/v3/f88a6f6a-0dc9-420e-ba23-89f0d3ded861.pdf"},{"id":171223,"identity":"b4533f74-c158-4cd5-825a-144630047b43","added_by":"auto","created_at":"2019-11-21 13:51:18","extension":"doc","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":141312,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITFillablechecklist.doc","url":"https://assets-eu.researchsquare.com/files/4657dfc2-1db4-4c80-824c-0f9de2a9173e/v3/SPIRIT_Fillable-checklist.doc"}],"financialInterests":"","formattedTitle":"Health Pregnancy, Healthy Baby: Testing the added benefits of pregnancy ultrasound for child development in a randomised control trial","fulltext":[{"header":"Background","content":"\u003cp\u003eMore than 250 million children younger than 5 years in low- and middle-income countries (43% of the total globally) are at risk of not reaching their developmental potential because they are stunted or live in extreme poverty. This rises to 70% of young children in Sub-Saharan Africa, which has the highest risk burden in the world (1). In South Africa (SA), the risk is 39% of children under 5 years of age, with knock-on losses of human capital due to inadequate school learning and low earning capacity (2). The Global Strategy for Women’s, Children’s and Adolescents’ Health (3), and the fourth Sustainable Development Goal (4) recognise the importance of promoting early childhood development (ECD) to ensure that children survive \u003cem\u003eand\u003c/em\u003e thrive, and rightfully fulfil their human potential and contribute productively to their families and societies.\u003c/p\u003e\n\n\u003cp\u003eThe 2017 Lancet Series \u003cem\u003eAdvancing Early Childhood Development: From Science to Scale,\u003c/em\u003e recommended that the contacts which the Reproductive, Maternal, Newborn and Child Health (RMNCH) services have with pregnant women, parents and families are important entry points to promote ECD (5). Further, it noted that many effective programmes for ECD are currently built on health services, demonstrating the feasibility of this approach for taking interventions to promote ECD to scale (2, 6).\u003c/p\u003e\n\n\u003cp\u003eIn 2015, South Africa adopted a National Integrated Early Childhood Development Policy that mandates the health sector to lead in providing services for children and families in the first 1000 days of life, starting from conception, in collaboration with other relevant sectors. Taking this up, the National Department of Health (NDoH) launched a Side-by-Side campaign (7) to bolster support for pregnant women and families with young children, and revised the Road to Health Booklet to emphasise survive and thrive.\u003c/p\u003e\n\n\u003cp\u003eThe 2015 NDoH Guidelines for Maternity Care in SA (8), recommend that all pregnant women attending a district hospital should have access to one ultrasound scan (US) 18–20 weeks gestation. The purpose of the US is to confirm an intra-uterine pregnancy, fetal viability, the number of fetuses, gestational age, location of the placenta and amniotic fluid volume. The 2016 WHO Antenatal Guidelines (9) recommend one US before 24 weeks gestation “to estimate gestational age, improve detection of fetal abnormalities and multiple pregnancies, reduce induction for post-term pregnancy, and improve a women’s pregnancy experience” (Recommendation B.2.4).\u003c/p\u003e\n\n\u003cp\u003eTaking advantage of the SA and WHO recommendations that pregnant women have an ultrasound examination before 24 weeks gestation, the aim of this three-arm trial is to assess whether messages to promote ECD delivered during pregnancy and one or two additional ultrasound examinations will increase parental investment in ECD as indexed by infant development, nutrition and growth, and the quality of parent-child relationships 6 weeks and 6 months post-partum.\u003c/p\u003e\n\n\u003ch2\u003eBenefits of pregnancy ultrasound\u003c/h2\u003e\n\u003cp\u003eIn addition to the survival and health benefits of US reviewed by WHO in preparation of the guidelines (10), the possibility is raised that US may increase antenatal clinic (ANC) use (11), particularly in view of the recommendation that ANC visits be increased from four to eight. However, the evidence on ultrasound, including any psychological benefits, is derived almost solely from high-income countries (HIC).\u003c/p\u003e\n\n\u003cp\u003eEarly pregnancy US have been routine in HICs for more than 30 years. At the time of introduction of US, studies reported positive parental reactions to seeing images of the fetus (12, 13), that parents enjoyed the experience and that they found it useful to receive information during US (14). Reading et al (15) commented on the potential of US to change parental behaviour for the better, such as smoking cessation during pregnancy. Rothenberg speculated that further research could “lead to the development of ultrasound use patterns designed to enhance maternal attachment”, and that “the psychosocial dimension of ultrasound scanning seems obvious to patients and personnel in the field” (16 p171).\u003c/p\u003e\n\n\u003cp\u003eIn qualitative studies, both mothers and fathers report enjoying the US experience and that the presence of the father seemed to have a beneficial effect on the mother (17). A 1999 review concluded that there was as yet no evidence of increases in health behaviours following US nor that ‘seeing the baby’ stimulates parental-fetal attachment (18). Based on their review, Baillie et al cautioned that “Practitioners and decision makers should be wary of over-interpreting enjoyment of a procedure as evidence of its therapeutic power” (18 p149). Later studies however report positive effects of US on maternal and paternal attachment (19–22) but only a few have examined the effects of US on attachment after birth (23, 24).\u003c/p\u003e\n\n\u003cp\u003eUS studies conducted in sub-Saharan Africa have principally focused on US costs, maintenance, training, human resources, acceptability, and other aspects of feasibility, including in Ghana (25), Kenya (26), Malawi (27), Nigeria (28–30), Rwanda (31) South Africa (32), Tanzania (33, 34) and Uganda (35, 36). In general US is thought to enhance antenatal care through confirmation of pregnancy status and more accurate estimation of gestational age, but concerns remain about feasibility of wide-scale use in low and middle-income countries and the potential misuse of US for sex determination in countries with high preference for male children (37). A recent large cluster-randomised control trial in Pakistan, Kenya, Zambia, DRC and Guatemala suggested that US did not increase ANC use or hospital births (38). However, a review in Sub-Saharan Africa concluded that “The potential benefits of obstetric ultrasound are yet to be fully realized in SSA due to challenges ranging from individual patients to institutional and national policies. While there may be conflicting evidence on the impact of universal access on perinatal outcomes, the region presents many research opportunities that could provide answers to these questions” (39 pE58).\u003c/p\u003e\n\n\u003cp\u003ePoint of Care Ultrasound (PoCUS) makes scale-up more feasible (39, 40) and evidence with its use more positive than standard US. A recent review (41) concluded that in every study in which it was examined in LMICs, PoCUS increased antenatal clinic attendance and assisted with the identification and treatment of conditions associated with maternal and neonatal morbidity in under-resourced settings. PoCUS thus has the potential to bring much-needed services to women in rural communities and in poor countries, many of whom need these services most. In addition to increasing access to services, US has also been found to provide an opportunity to engage fathers (42), with the potential of garnering support for the expectant mother and their child and potential sharing of childcare responsibilities.\u003c/p\u003e\n\n\u003cp\u003eThis study examines US augmented with messages about foetal and infant development and the importance of parent wellbeing and infant care on postnatal care and early childhood development. We hypothesise that one or two US with messages about fetal and infant development will have a positive effect on infant development at 6 months post-natal, as well as on parental wellbeing, parent-child attachment, infant feeding and growth and use of preventive health care services.\u003c/p\u003e"},{"header":"Methods","content":"\u003ch2\u003eObjectives\u003c/h2\u003e\n\u003cp\u003eThe trial will evaluate the potential benefits of US on early childhood development and child care by augmenting a routine antenatal service currently provided mainly in tertiary public health facilities in South Africa, with plans to be rolled out to district hospitals. The goal of the intervention is to increase parental investment not only in child survival, but also for the wellbeing and healthy growth and development of their child. We aim to establish whether, compared to routine care, messages about fetal and child development delivered during one (\u0026lt;25 weeks) or two (\u0026lt; 25 weeks and again \u0026lt;36 weeks) fetal ultrasounds improve ECD and growth, exclusive breastfeeding, mother/father-infant attachment, maternal and paternal well-being, father involvement and pre- and post-natal clinic attendance.\u003c/p\u003e\n\n\u003cp\u003eSpecific objectives are to evaluate whether child development messages delivered during one or two ultrasounds:\u003c/p\u003e\u003cul\u003e\u003cli\u003eImprove early child development\u003c/li\u003e\u003cli\u003eImprove infant breastfeeding practices and healthy child growth\u003c/li\u003e\u003cli\u003eImprove parent-infant attachment and interaction during pregnancy and six months after birth\u003c/li\u003e\u003cli\u003eIncrease paternal engagement in a young child’s development and care\u003c/li\u003e\u003c/ul\u003e\n\n\u003ch2\u003eDesign\u003c/h2\u003e\n\u003cp\u003eEligible mothers will be randomised to one of three arms. Arm 1, the control group, will receive standard practice of care during pregnancy; arm 2 will receive the child development intervention at the first research ultrasound visit, and arm 3 will receive the intervention at two research ultrasound visits. All mothers, infants and partners (where available) will be followed-up 6 weeks and 6 months postnatally for assessments. Participants will continue to receive routine ante-, peri- and postnatal care as provided by the tertiary care facility from which all participants are being recruited from.\u003c/p\u003e\n\n\u003ch2\u003eSetting\u003c/h2\u003e\n\u003cp\u003eThe study is situated in Soweto, South Africa. Soweto is adjacent to Johannesburg and is the most populous Black urban residential area in South Africa with over 1.3 million people counted in the most recent census (43). Participants will be recruited from women attending antenatal care at Chris Hani-Baragwanath Academic Hospital (CHBH), a tertiary teaching hospital that attends to over 22,000 births annually. Women are referred to CHBH from community health centres with risk factors including HIV and hypertension. Recruited women will attend their study ultrasound visits at the SAMRC Development Pathways for Health Research Unit (DPHRU), which is located on the grounds of CHBH and in walking distance of the CHBH antenatal services.\u003c/p\u003e\n\n\u003ch2\u003eProcedures\u003c/h2\u003e\n\u003ch2\u003eRecruitment\u003c/h2\u003e\n\u003cp\u003eApproximately 500 women present to CHBH each month for their first pregnancy ultrasound, of which, 50 percent are \u0026lt;25 weeks gestation. This offers a potential pool of 250 women a month to be included in the study. Participants will be recruited from women attending the Foetal Medicine Unit (FMU) at CHBH, where routine fetal ultrasounds are conducted. Eligible women will be resident within Soweto, 18 years and older, with a singleton pregnancy and presenting \u0026lt;25 weeks gestation. Major fetal abnormalities detected during the first routine ultrasound conducted by an experienced radiologist in the FMU, or severe maternal morbidities, will exclude a pregnant woman from the trial. These women will be transferred to specialised clinical services at CHBH where she will receive appropriate treatment.\u003c/p\u003e\n\n\u003cp\u003eSample size calculations were based on detecting a 0.5 standard deviation (SD) difference between arms on both the Bayley III Language and Cognitive Scales, and z-scores for weight-for-age (WAZ), length-for-age (LAZ) and weight-for-length (WLZ) measured at 6 months of age at 90% power, which is 85 per arm. Allowing for 15% potential attrition during pregnancy and during follow-up to six months of infant age, sample size in each of the three arms will be 100. This makes a total sample size of 300 women for recruitment.\u003c/p\u003e\n\n\u003ch2\u003eIntervention\u003c/h2\u003e\n\u003cp\u003eWomen will be randomised to one of three arms on recruitment at CHBH \u0026lt;25 weeks gestation after having a fetal ultrasound as part of routine antenatal hospital services. The women will be blind to their arm allocation and remain blinded until study completion. Using computer-generated simple randomisation, each consecutive woman screened will be randomly allocated to a study arm. Research assistants responsible for screening will receive the study arm numbers for allocation from the study coordinator on a daily basis. The allocation sequence will be concealed from the research assistants enrolling the participants. Women recruited for arm 1 will act as the control group and will receive one further standard US at DPHRU \u0026lt;25 weeks gestation when they will receive standard fetal growth measurements, but no child development messages.\u003c/p\u003e\n\n\u003cp\u003eIn addition to their routine antenatal US at CHBH, women recruited to arm 2 will receive an additional US \u0026lt;25 weeks gestation at DPHRU, during which they will receive messages to promote early childhood development. During the US session, the sonographer will talk with the mother and partner, if present, about the fetus’ sensory development and capacity for learning, fetal responsivity to the environment, maternal wellbeing and the dependence of the fetus on maternal and paternal health and wellbeing before and after birth.\u003c/p\u003e\n\n\u003cp\u003eIn addition to their routine antenatal US at CHBH, women recruited to arm 3 will receive two additional USs at DPHRU, one \u0026lt;25 weeks gestation (early US) and another \u0026lt; 36 weeks gestation (late US). They will receive the same child development messages as mothers in arm 2 at the first US. During the second US, in addition to childhood development messages, the sonographer will encourage the woman and her partner, if present, to personalise the baby, strengthen intentions to exclusively breastfeed, talk and sing to the child before and after birth, and counsel them on how to respond to their young infants emotional and learning needs.\u003c/p\u003e\n\n\u003cp\u003ePartner involvement and interest in the baby is encouraged by inviting partners to attend the ultrasound sessions of women in all three arms. For mothers recruited to arms 2 and 3, digital ultrasound images and a photograph of the woman (with her partner where present) having the US will be sent to parents via \u003cem\u003eWhatsApp\u003c/em\u003e and printed images given to the parents. A small baby book with the child development messages, as appropriate to the arm, is given to the mothers in arms 2 and 3, and they are encouraged to paste the printed pictures into the book and to share the US images and photographs with family and friends.\u003c/p\u003e\n\n\u003cp\u003eTwo qualified and registered sonographers will be trained to deliver the intervention and a Philips HD9 Ultrasound System will be used to conduct all ultrasounds. Due to the nature of the intervention, the sonographers will not be blind to the mother arm allocation.\u003c/p\u003e\n\n\u003ch2\u003eData collection\u003c/h2\u003e\n\u003cp\u003eStudy data will be collected and managed using REDCap (Research Electronic Data Capture) hosted by the University of the Witwatersrand. Data will be collected on the enrolled women, child and partners (where appropriate) at three stages; 1) baseline at first research ultrasound at DPHRU \u0026lt;25 weeks; 2) 6-week post-natal follow-up, and 3) 6-month post-natal follow-up. Data will be collected on tablets at stages one and two by two trained data collectors under the supervision of the study coordinator. At stage three, data will be collected by occupational therapists or physiotherapists trained in administering child development measures, under the supervision of the study coordinator. All data collectors will be trained on the principles of research ethics, good clinical practice, referral procedures and management of difficult situations in the field.\u003c/p\u003e\n\n\u003cp\u003eTable 1 shows the schedule of enrolment, interventions and data collection.\u003c/p\u003e\n\u003cp\u003e[Table 1 placed here]\u003c/p\u003e\n\n\u003cp\u003eThe data collected at each stage is as follows:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eBaseline at first research ultrasound at DPHRU. \u003c/em\u003eData at the first research visit (\u0026lt;25weeks) will include participant contact details, demographic characteristics and reproductive history, socio-economic status, social and instrumental support, and breastfeeding intentions. Maternal and paternal fetal attachment is assessed using the Maternal and Paternal Attachment Scales (44, 45), and the mother and her partner, if available, will complete a social support questionnaire and the Edinburgh Postnatal Depression Scale (46). The woman and her partner, if available, will also be asked to complete an ultrasound experience questionnaire after the US.\u003c/p\u003e\n\n\u003cp\u003e\u003cem\u003eSix week postnatal follow-up. \u003c/em\u003eTwo trained outcome assessors, blind to the mother’s arm allocation, will complete the follow-up questionnaires with the mothers, infants and partners, where available. Questionnaires will assess perinatal and postnatal information, breastfeeding practices and partner and social support. Postnatal depression will be assessed for the mother and partner using the Edinburgh Postnatal Depression Scale. Infant growth will be assessed using standard procedures for infant weight and length (the SECA 416 infantometer for length and the SECA 367 infant scale for weight). Measures will be converted to z-scores using the 2006 WHO Growth Standards for LAZ, WAZ and WLZ. Birth weight and length as well as key information on maternal and infant birth outcomes will be collected from the infant’s Road to Health Booklet.\u003c/p\u003e\n\n\u003cp\u003e\u003cem\u003eSix month postnatal follow-up.\u003c/em\u003e Occupational therapists or physiotherapists trained in child development will complete the six-month follow-up assessments with the mothers, infants and partners, where available. The primary outcome for the six-month follow-up is child development as measured by the Bayley Scales of Infant and Toddler Development, Third edition (47).\u003c/p\u003e\n\n\u003cp\u003eAll the study outcome measures are shown in Table 2.\u003c/p\u003e\n\u003cp\u003e[Table 2 placed here]\u003c/p\u003e\n\n\u003ch2\u003eFormative and process data\u003c/h2\u003e\n\u003cp\u003eStudy procedures were informed by formative qualitative research conducted with pregnant women attending antenatal care at CHBH prior to the trial inception. We have written standard operating procedures (SOPs) to support the research team to deliver the study procedures and intervention according to the protocol. Participant adherence will be assessed by counts (for example, visit attendance) and intervention delivery will be monitored by observing contacts between the sonographer (who will conduct the ultrasound and deliver the ECD messages) and participants (intervention and control) to record the nature of interactions. We will monitor intervention dose and experience by recording the duration of the ultrasound visit (with and without delivery of the intervention) and by gathering participant and partner views on the ultrasound experience. Ongoing consultation with a key stakeholder network will inform intervention procedures and assist with contextualising the intervention and addressing any challenges that may arise during trial implementation.\u003c/p\u003e\n\n\u003cp\u003eDue to the well-documented challenges with engaging men in research and health care in South Africa, (54) we will adopt pro-active recruitment strategies, which will include phone calls to partners after participant enrolment and follow-up calls closer to the visit to encourage attendance. We have also included Saturday sessions for those partners who are unable to attend during the week due to work commitments. Research staff will make regular contact with participants in-between study visits to maintain accuracy of records and to promote retention of participants in the study. We will follow up participants who default and those who withdraw to gain an understanding of why they dropped out during the course of the trial.\u003c/p\u003e\n\n\u003ch2\u003eData analysis\u003c/h2\u003e\n\u003cp\u003eAll available data at baseline will be analysed descriptively for each intervention group and in total. Categorical data will be summarised by numbers and percentages. Continuous data will be summarised by mean, SD and range if data are normal and median, IQR and range if data are skewed. Minimum and maximum values will also be presented for continuous data. Differences regarding baseline variables will be checked for clinical relevance between the three treatment groups.\u003c/p\u003e\n\n\u003cp\u003eA CONSORT flow diagram will be used to summarise the number of participants who were: assessed for eligibility at screening, were eligible at screening, eligible and randomised, lost to or discontinued the intervention, included in the primary outcome analysis. If possible respondents and non-respondents will be compared.\u003c/p\u003e\n\n\u003cp\u003eThe analysis of the primary outcome will be performed on the intention to treat population with no imputation of missing data. In the primary analysis, child development scores will be compared to the control group. If outcome data are normally distributed, we will fit linear regression models. If not normally distributed, outcome data will be categorised and logistic regression methods will be used to assess differences between intervention and control groups. Tests will be two-sided with a significance level of 0.05 and 95% Confidence Intervals will also be reported. In case of relevant differences in baseline characteristics additional adjustment(s) for these factors will be performed within the models to address potential confounding.\u003c/p\u003e\n\n\u003cp\u003eA stratified analysis will be done for three pair-wise comparisons, i.e. Arm 1 vs. control, Arm 2 vs. control, Arm 1 vs. Arm 2 (as described in \u003ca\u003e6.2\u003c/a\u003e) according to the following subgroups: Partner vs no partner accompaniment and parity.\u003c/p\u003e\n\n\u003cp\u003eSTATA, Version 15 (StataCorp, College Station, Texas, USA) will be used for all analyses. Missing data and data from those who withdraw from the study will not be interpreted.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eWhile ultrasound has long been regarded as having potential to be transformative and to improve parental behaviour (14) as well as commitment to the growing child (12), this hypothesis has only been tested in a few studies in high-income countries, fewer of which were randomised control trials (55).\u003c/p\u003e\n\n\u003cp\u003eThere is clear evidence from high-income countries that the first time a prospective mother sees an image of their fetus during ultrasound is an emotionally enjoyable experience, which parents report intensifies their attachment to the coming baby. This is true also of prospective fathers (22, 56), and is reported as being an important bonding experience for the family (57). A number of studies have examined the impact of ultrasound on maternal attachment (24, 58, 59). However, women’s experiences of ultrasound are dependent on the context and the behaviour of the sonographer, with some women reporting feeling objectified and poorly informed during the experience (60).\u003c/p\u003e\n\n\u003cp\u003eResearch on the emotional and relationship effects of early ultrasound are important because maternal (and presumably paternal) representations of the coming baby are significant predictors of parent-infant interactions which, in turn, affect healthy infant development (61, 62). A recent review of interventions indicated that awareness programmes, most commonly involving pregnancy ultrasound, were amongst the most promising interventions to increase parent-fetal attachment (55). There is agreement that studies are needed which follow up parental-child behaviour and healthy child development post-natally, include fathers, and examine the construct in a wider diversity of settings, including in low- and middle-income countries. Testing the added benefits of pregnancy ultrasound for child development is the gap that the proposed randomised control trial in South Africa seeks to address.\u003c/p\u003e\n\n\u003cp\u003eShould this trial demonstrate feasibility and improvement in the specified intermediate and outcome measures, the next step would be a pragmatic trial situated in the health care system, with longer-term outcomes and cost-effectiveness estimations.\u003c/p\u003e\n\n\u003ch2\u003eDissemination policy\u003c/h2\u003e\n\u003cp\u003eWe will share the study results with the trial stakeholder network, including the study participants (where requested), the South African Ministry of Health and relevant clinical, academic and research partners. We will also publish the results after study completion. Authorship will include the co-investigators as well as any post-gradaute students who may contribute substantially to analysis and writing of a particular paper. Professional writers will not be used.\u003c/p\u003e\n\n\u003ch2\u003eTrial status\u003c/h2\u003e\n\u003cp\u003eThe trial protocol, version number 2.0, was approved on 16 January 2019 and is ongoing. The recruitment began on 1March 2019 and was completed on 30 September 2019. Trial procedures are expected to be complete by the end of July 2020.\u003c/p\u003e\n"},{"header":"Abbreviations","content":"\u003cp\u003eANCAntenatal clinic\u003c/p\u003e\n\u003cp\u003eBayleyIIIBayley Scales of Infant and Toddler Development, Third Edition\u003c/p\u003e\n\u003cp\u003eCHBHChris Hani-Baragwanath Hospital\u003c/p\u003e\n\u003cp\u003eDPHRUDevelopmental Pathways to Health Research Unit\u003c/p\u003e\n\u003cp\u003eECDEarly childhood development\u003c/p\u003e\n\u003cp\u003eFMUFoetal Medicine Unit\u003c/p\u003e\n\u003cp\u003eHICHigh income country\u003c/p\u003e\n\u003cp\u003eNDoHNational Department of Health\u003c/p\u003e\n\u003cp\u003eSASouth Africa\u003c/p\u003e\n\u003cp\u003eUSUltrasound\u003c/p\u003e\n\u003cp\u003eWHOWorld Health Organization\u003c/p\u003e\n"},{"header":"Declarations","content":"\u003ch3\u003eEthics approval and consent to participate\u003c/h3\u003e\n\u003cp\u003eThe study has been approved by the Human Research Ethics Committee (Medical) of the University of the Witwatersrand, South Africa (M181915) and the Medical Advisory Committee of CHBH who oversee adherence to the study protocol. Both mothers and fathers provide written informed consent. The participants provide written consent for the publication of group results from the study. Participants will be given a numerical identifier and all personal information will remain confidential.\u003c/p\u003e\n\n\u003cp\u003eBecause the participants are initially screened through the Foetal Medicine Unit at CHBH, the study team envisage minimal risk to the pregnant women (or foetuses) and infants. However, any indications of negative effects or complications will be actioned swiftly. If it is thought that the woman or her baby may have a health problem (physical or mental) or if any changes or abnormalities are detected at a study visit, the participants will be referred to a trained nurse at the DPHRU research site who will make further enquiries, provide participants and facilitate the necessary referrals to CHBH departments. A senior clinician from CHBH is included in the investigator team and theywho will assist in ensuring swift referral, management and follow up of women enrolled in the study at the hospital. Women or their partners requiring psychological support will be referred to an onsite professional nurse at the research site for further assessment and counselling. There is an established network of referral bodies within the public health sector and supporting NGOs for further management. Research staff will enquire about any incidents or changes since a participant’s last visit and these will be documented and actioned, if needed. Any adverse effects as a result of the trial will be reported to the ethical committee, and participants will be referred to the clinical services provided at CHBH.\u003c/p\u003e\n\n\u003cp\u003eAny modifications to the protocol will be communicated to the funders and the ethical committees. In addition, the Trial Advisory Committee for this study consists of leading international researchers and clinicians in the fields of maternal and child health, as well as mental health, who will play a direct role in the oversight and monitoring of the study procedures and progress.\u003c/p\u003e\n\n\u003ch3\u003eConsent for Publication\u003c/h3\u003e\n\u003cp\u003eNot Applicable\u003c/p\u003e\n\n\u003ch3\u003eAvailability of data and materials\u003c/h3\u003e\n\u003cp\u003eThe questionnaires and coding sheets used in the study, as well as anonymised data, will be included in or as supplementary files to articles published, as required. Trial results will be disseminated to participants and relevant health care providers via a stakeholder committee.\u003c/p\u003e\n\n\u003ch3\u003eCompeting interests\u003c/h3\u003e\n\u003cp\u003eEach of the authors declare that they have no competing interests\u003c/p\u003e\n\n\u003ch3\u003eFunding\u003c/h3\u003e\n\u003cp\u003eThis project is supported by Saving Brains. Saving Brains is a partnership of Grand Challenges Canada, the Aga Khan Foundation Canada, the Bernard van Leer Foundation, the Bill \u0026amp; Melinda Gates Foundation, The ELMA Foundation, Grand Challenges Ethiopia, the Maria Cecilia Souto Vidigal Foundation, the Palix Foundation, the UBS Optimus Foundation and World Vision Canada (SB-POC–1810–19664). The funders have no role in study design, data collection, management and analysis. The authors are responsible for the monitoring of data and act independently from the funders.\u003c/p\u003e\n\n\u003ch3\u003eAuthors’ contributions\u003c/h3\u003e\n\u003cp\u003eLMR wrote the paper. WS, SAN, AS, LP and DP made substantial contributions and approved the final version for publication\u003c/p\u003e\n\n\u003ch3\u003eAcknowledgements\u003c/h3\u003e\n\u003cp\u003eWihan Taljaard, Lukhanyo Nyati and Roisin Drysdale provided research support.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003eBlack MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, et al. Early childhood development coming of age: science through the life course. Lancet. 2017;389:77–90.\u003c/li\u003e\u003cli\u003eRichter LM, Daelmans B, Lombardi J, Heymann J, Boo FL, Behrman JR, et al. Investing in the foundation of sustainable development: pathways to scale up for early childhood development. Lancet. 2017;389:103–18.\u003c/li\u003e\u003cli\u003eEvery Women Every Child. 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Expectant fathers’ presence at prenatal ultrasounds: An opportunity for engagement. Soc Work Res. 2017;41:181–5.\u003c/li\u003e\u003cli\u003eStatistics South Africa. http://www.statssa.gov.za/. Accessed 12 Aug 2019.\u003c/li\u003e\u003cli\u003eCondon JT. The assessment of antenatal emotional attachment: Development of a questionnaire instrument. Br J Med Psychol. 1993;66:167–83.\u003c/li\u003e\u003cli\u003eCondon JT, Boyce P, Corkindale CJ. The First-Time Fathers Study: a prospective study of the mental health and wellbeing of men during the transition to parenthood. Aust N Z J Psychiatry. 2004;38:56–64.\u003c/li\u003e\u003cli\u003eCox DN, Wittman BK, Hess M, Ross AG, Lind J, Lindahl S. The psychological impact of diagnostic ultrasound. Obstet Gynecol. 1987;70:673–6.\u003c/li\u003e\u003cli\u003eBayley N. Bayley scales of infant and toddler development: Bayley-III. San Antonio, Texas: Harcourt Assessment 2006.\u003c/li\u003e\u003cli\u003eBallot DE, Ramdin T, Rakotsoane D, Agaba F, Davies VA, Chirwa T, Cooper PA. Use of the Baley scales of infant and toddler development, third edition, to assess developmental outcomes in infants and young children in an urban setting in South Africa. Int Sch Res Notices. 2017;2017:1631760.\u003c/li\u003e\u003cli\u003eFrankenburg WK, Coons CE. Home screening questionnaire: its validity in assessing home environment. J Pediatr. 1986;108:624–6.\u003c/li\u003e\u003cli\u003eGrieve KW, Richter LM. A factor analysis study of the home screening questionnaire for infants. S Afr J Psychol. 1989;20:277–81.\u003c/li\u003e\u003cli\u003eRichter LM, Grieve KW, Austin D. Scaffolding by Bantu mothers during object play with their infants. Early Child Dev Care. 1988:34.\u003c/li\u003e\u003cli\u003eLawrie TA, Hofmeyr GJ, de Jager M, Berk M. Validation of the Eginburgh Postnatal Depression Scale on a cohort of South African women. S Afr Med J. 1998;88:1340–4.\u003c/li\u003e\u003cli\u003eVen Heyningen T, Honikman S, Tomlinson M, Field S, Myer L. Comparison of mental health screening tools for detecting antenatal depression and anxiety disordersin South African women. PLoS One. 2018;13.\u003c/li\u003e\u003cli\u003eMakusha T, Richter LM. Father involvment in the first 1,000 days. In: van den Berg W, Makusha T, editors. State of South Africa’s fathers 2018. Cape Town: Sonke Gender Justice and Human Sciences Research Council; 2018. p. 49–64.\u003c/li\u003e\u003cli\u003eCunen NB, Jomeen J, Xuereb RB, Poat A. A narrative review of interventions addressing the parental–fetal relationship. Women Birth. 2017;30:e141–51.\u003c/li\u003e\u003cli\u003eDraper J. ‘It’s the first scientific evidence’: men’s experience of pregnancy confirmation. J Adv Nurs. 2002;39:563–70.\u003c/li\u003e\u003cli\u003eEkelin M, Crang-Svalenius E, Dykes AK. A qualitative study of mothers’ and fathers’ experiences of routine ultrasound examination in Sweden. Midwifery. 2004;20:335–44.\u003c/li\u003e\u003cli\u003eAlhusen JL. A literature update on maternal‐fetal attachment. Journal of Obstetric, Gynecologic, \u0026amp; Neonatal Nursing. 2008;37:315–28.\u003c/li\u003e\u003cli\u003eCannella BL. Maternal–fetal attachment: an integrative review. J Adv Nurs. 2005;50:60–8.\u003c/li\u003e\u003cli\u003eVan der Zalm JE, Byrne PJ. Seeing baby: women’s experience of prenatal ultrasound examination and unexpected fetal diagnosis. J Perinatol. 2006;26(7):403.\u003c/li\u003e\u003cli\u003eBarlow J. The relationship with the unborn baby: Why it matters? Int J Birth Parent Educ. 2016;4:5.\u003c/li\u003e\u003cli\u003eCataudella S, Lampis J, Busonera A, Marino L, Zavattini GC. From parental-fetal attachment to a parent-infant relationship: a systematic review about prenatal protective and risk factors. Life Span and Disability. 2016;19:185–219.\u003c/li\u003e\u003c/ol\u003e\n"},{"header":"Tables","content":"\u003cp style=\"margin-bottom: .0001pt; line-height: 200%; page-break-after: avoid;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 200%; font-family: 'Times New Roman',serif; color: windowtext;\"\u003eTable \u003c/span\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 200%; font-family: 'Times New Roman',serif; color: windowtext;\"\u003e1\u003c/span\u003e\u003c/strong\u003e \u003cspan style=\"font-size: 12.0pt; line-height: 200%; font-family: 'Times New Roman',serif; color: windowtext;\"\u003eStandard Protocol Items: Recommendations for Interventional Trials (SPIRIT) showing the schedule of enrolment, interventions and data collection\u003c/span\u003e\u003c/p\u003e\n\u003ctable style=\"width: 100.0%; border-collapse: collapse; border: none;\" width=\"100%\"\u003e\n\u003ctbody\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"margin-bottom: 12.0pt; text-align: center;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 74.38%; border: solid #262626 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" colspan=\"5\" width=\"74%\"\u003e\n\u003cp style=\"margin-bottom: 12.0pt; text-align: center;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eSTUDY PERIOD\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eEnrolment\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 27.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" colspan=\"2\" width=\"27%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eIntervention\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 29.86%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" colspan=\"2\" width=\"29%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eFollow-up \u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; background: #E6E6E6; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; color: black;\"\u003eTIMEPOINT\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border: none; border-right: solid #262626 1.5pt; background: #E6E6E6; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; color: black;\"\u003e\u0026lt;22 weeks GA\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: #E6E6E6; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; text-align: center;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; color: black;\"\u003e\u0026lt;25\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp style=\"margin-bottom: .0001pt; text-align: center;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; color: black;\"\u003eweeks GA\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; background: #E6E6E6; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; color: black;\"\u003e\u0026lt;36 weeks GA \u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: #E6E6E6; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; color: black;\"\u003e6 weeks postnatal\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: #E6E6E6; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; color: black;\"\u003e6 months postnatal\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eENROLMENT:\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 74.38%; border: solid #262626 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" colspan=\"5\" width=\"74%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eEligibility screen\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eInformed consent \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eRandom allocation\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eINTERVENTIONS:\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 74.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" colspan=\"5\" width=\"74%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eEarly US\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eEarly US with messages\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eEarly and late US with messages\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 100.0%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" colspan=\"6\" width=\"100%\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eASSESSMENTS: BASELINE AND ANTENATAL \u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eSocio-demographic questionnaire\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: white; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eFetal growth assessment\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: white; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eSocial support \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: white; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eMaternal and Paternal antenatal depression and anxiety \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: white; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eMaternal and Paternal antenatal attachment\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: white; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eMaternal and paternal antenatal depression\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: white; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eUS experiences questionnaire\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: white; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 100.0%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" colspan=\"6\" width=\"100%\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eOUTCOMES: PRIMARY AND SECONDARY\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eBayley Scales of Infant and Toddler Development (3\u003csup\u003erd\u003c/sup\u003e\u0026nbsp; edition)\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eHome Screening Questionnaire\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eMother/father-infant interaction\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003ePerinatal and postnatal information \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eInfant behaviour (crying, sleeping etc.)\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eBreastfeeding practices questionnaire\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eMaternal and paternal postnatal depression and anxiety\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eSocial support\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003ePartner involvement\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: white; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; color: black;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eInfant growth \u0026ndash; weight and length\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; background: white; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif; color: black;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eImmunisation status\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr style=\"height: 1.0pt;\"\u003e\n\u003ctd style=\"width: 25.62%; border: solid #262626 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"25%\"\u003e\n\u003cp style=\"text-align: right;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eClinic attendance\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 17.14%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"17%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.38%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 13.0%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.5pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"13%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.9%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 14.96%; border-top: none; border-left: none; border-bottom: solid #262626 1.0pt; border-right: solid #262626 1.0pt; padding: 0in 5.4pt 0in 5.4pt; height: 1.0pt;\" width=\"14%\"\u003e\n\u003cp style=\"text-align: center;\"\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 107%; font-family: 'Times New Roman',serif;\"\u003eX\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: 200%; page-break-after: avoid;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; line-height: 200%; font-family: 'Times New Roman',serif; color: windowtext;\"\u003eTable 2\u003c/span\u003e\u003c/strong\u003e \u003cspan style=\"font-size: 12.0pt; line-height: 200%; font-family: 'Times New Roman',serif; color: windowtext;\"\u003eStudy Outcome Measures \u003c/span\u003e\u003c/p\u003e\n\u003ctable style=\"border-collapse: collapse; border: none;\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 81.6pt; border: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"109\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; text-align: center; line-height: normal;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eOUTCOME\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 102.45pt; border: solid windowtext 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"137\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; text-align: center; line-height: normal;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eINSTRUMENT\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 106.3pt; border: solid windowtext 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"142\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; text-align: center; line-height: normal;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eMEASURE\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 177.2pt; border: solid windowtext 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"236\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; text-align: center; line-height: normal;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eDESCRIPTION\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border: solid windowtext 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; text-align: center; line-height: normal;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eMETHOD OF AGGREGATION \u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border: solid windowtext 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; text-align: center; line-height: normal;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eTIMEPOINT\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 467.55pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;\" colspan=\"4\" width=\"623\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003ePrimary outcome \u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 81.6pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;\" rowspan=\"2\" width=\"109\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eChild development at 6 months \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 102.45pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"137\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eBayley Scales of Infant and Toddler Development (3\u003csup\u003erd\u003c/sup\u003e edition) (Bayley III)\u003c/span\u003e\u003c/p\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 106.3pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"142\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eThe total score from each developmental domain\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 177.2pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"236\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eThe Bayley III is an individually administered assessment of a child\u0026rsquo;s attainment of developmental milestones across five domains, i.e. cognitive, language, motor, social-emotional and adaptive skills (47). It has been recognised internationally as the most comprehensive tool to assess children from as young as one month old and has been validated in South Africa (48)\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eIndividual scores to be compared between intervention and control groups using linear or logistic regression models dependant on the distribution of the data. \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eEnd point\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 102.45pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"137\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eHome Screening Questionnaire (HSQ)\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 106.3pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"142\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eHSQ score\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 177.2pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"236\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eThe Home Screening Questionnaire (HSQ), a 30-item parent-report tool, used to identify features of the home environments related to childhood development (49). The HSQ has been validated and used for research purposes in a number of countries, including South Africa (50). \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eIndividual scores to be compared between intervention and control groups using linear or logistic regression models dependant on the distribution of the data.\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eEnd point\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 467.55pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;\" colspan=\"4\" width=\"623\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eSecondary outcomes\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 81.6pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"109\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eMother/father-infant interaction at 6 months \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 102.45pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"137\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eMother/father interaction rating scale\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 106.3pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"142\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eInteraction score\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 177.2pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"236\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eRated from a 5-minute videotape of mother/father and infant \u0026ldquo;talking and playing with each other\u0026rdquo; with the infant in a high chair, mother sitting on a chair at the same height opposite the infant and an attractive stack toy for them to share. We will use an adapted coding schemes developed by Richter to code engagement (eye contact, joint attention), emotional tone, emotional regulation (maternal/paternal comforting for distress), maternal/paternal responsiveness, and maternal/paternal scaffolding (51). \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eIndividual scores to be compared between intervention and control groups using linear or logistic regression models dependant on the distribution of the data.\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eEnd point\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 81.6pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"109\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eInfant growth at 6 weeks and 6 months\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 102.45pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"137\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eWeight and length \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 106.3pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"142\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eWeight (grams)\u003c/span\u003e\u003c/p\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eLength (cms)\u003c/span\u003e\u003c/p\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eWeight-for-age z-score (WAZ)\u003c/span\u003e\u003c/p\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eLength-for-age z-score (LAZ)\u003c/span\u003e\u003c/p\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eWeight-for-length z-score (WLZ)\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 177.2pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"236\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eInfant growth will be measured using standard procedures for infant weight and length, and converted to z-scores using the 2006 WHO Growth Standards (WAZ, LAZ and WLZ). \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eDifferences in mean weight and length of infants will be compared between intervention and control groups\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eIntermediate and end point \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 81.6pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"109\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eBreastfeeding practices at 6 weeks and 6 months\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 102.45pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"137\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eMaternal self-report questionnaire \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 106.3pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"142\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eBreastfeeding initiation and duration \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 177.2pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"236\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eInformation on breastfeeding practices will be collected by trained interviewers using a semi-structured questionnaire. \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eCategorical data will be presented as numbers and percentages. Changes in breastfeeding practices will be compared between intervention and control groups. \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eIntermediate and end point\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 81.6pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"109\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eMaternal and paternal postnatal depression and anxiety during pregnancy, at 6 weeks and 6 months\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 102.45pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"137\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eEdinburgh Postnatal Depression Scale (EPDS)\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 106.3pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"142\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eEPDS score\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 177.2pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"236\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eThe EPDS is a screening tool for antenatal and postnatal depressive symptoms among women. \u003c/span\u003e\u003c/p\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eThe EPDS has been validated for use antenatally and postnatally in a number of settings, including South Africa (52, 53).\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eProportion of mothers/partners showing signs indicative of depression will be compared during pregnancy, 6 weeks and 6 months. Data will be summarised by mean, SD and range at each time point.\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eBaseline, intermediate and end point\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 81.6pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"109\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eImmunisation status and clinic attendance at 6 weeks and 6 months\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 102.45pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"137\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eRoad to Health Booklet (child health record) or maternal/paternal self-report\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 106.3pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"142\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eClinic attendance at routine child services (immunisation, growth monitoring, developmental screening, Vitamin A, deworming).\u003c/span\u003e\u003c/p\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eOther health contacts (e.g. sick child care)\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 177.2pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"236\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eCategorical data will be presented as numbers and percentages with comparisons in proportions made at 6 weeks and 6 months. \u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eIntermediate and end point\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 81.6pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;\" width=\"109\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003ePartner involvement during pregnancy, at 6 weeks and 6 months \u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 102.45pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"137\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eMaternal/paternal self-report\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 106.3pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"142\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003ePartner involvement in child care\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 177.2pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"236\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eInformation on partner involvement in child care will be collected by trained interviewers using a semi-structured questionnaire.\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 127.55pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"170\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eCategorical data will be presented as numbers and percentages with comparisons in proportions made at 6 weeks and 6 months. \u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 85.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;\" width=\"113\"\u003e\n\u003cp style=\"margin-bottom: .0001pt; line-height: normal;\"\u003e\u003cspan style=\"font-size: 12.0pt; font-family: 'Times New Roman',serif;\"\u003eBaseline, intermediate and end point\u003c/span\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Fetal ultrasound Antenatal attachment Early childhood development Mother-child interaction Growth Pregnancy/antenatal","lastPublishedDoi":"10.21203/rs.2.13300/v3","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.2.13300/v3","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground The 2016 World Health Organization Antenatal Guidelines and the 2015 South African Maternal and Child Health Guidelines recommend one early antenatal ultrasound scan to establish gestational age and to detect multiple pregnancies and fetal abnormalities. Prior research indicates that ultrasound can also increase parental-fetal attachment. We aim to establish whether, compared to routine care, messages to promote parental attachment and healthy child development, conducted during one or two pregnancy ultrasounds improve early child development and growth, exclusive breastfeeding, parental-child interactions and pre- and post-natal clinic attendance. \u003c/p\u003e\u003cp\u003eMethods The effect of messages to sensitise mothers and fathers to fetal development will be tested in a 3-armed randomised trial with 100 mothers and their partners from Soweto-Johannesburg in each arm. The primary outcome is child development at 6 months post-natal. Secondary outcomes include infant feeding, parental attachment and interaction, parental mental health and infant growth, assessed at 6 weeks and 6 months. Parents in Arm 1 receive a fetal ultrasound \u0026lt;25 weeks during routine antenatal care at tertiary hospitals, and a second standard ultrasound at the research site within 2 weeks. Arm 2 participants receive the routine antenatal ultrasound and an additional ultrasound \u0026lt;25 weeks at the research site, together with messages to promote parental attachment and healthy child development. Arm 3 participants receive the routine ultrasound and two additional ultrasounds at the research site, \u0026lt;25 weeks and \u0026lt;36 weeks, together with messages to promote parental attachment and healthy child development. \u003c/p\u003e\u003cp\u003eDiscussion Evidence from high-income countries suggests that first-time prospective mothers and fathers enjoy seeing their fetus during ultrasound and that it is an emotional experience. A number of studies have found that ultrasound increases maternal attachment during pregnancy, a predictor of positive parent-infant interactions which, in turn, promotes healthy infant development. It is generally agreed that studies are needed which follow up parental-child behaviour and healthy child development postnatally, include fathers, and examine the construct in a wider diversity of settings, especially in low- and middle-income countries. Testing the added benefits of pregnancy ultrasound for child development is a gap that the proposed trial in South Africa seeks to address. \u003c/p\u003e\u003cp\u003eTrial Registration The trial is registered with the Pan African Clinical Trials Registry (https://pactr.samrc.ac.za) on 15 August 2018 (identifier: PACTR201808107241133).\u003c/p\u003e","manuscriptTitle":"Health Pregnancy, Healthy Baby: Testing the added benefits of pregnancy ultrasound for child development in a randomised control trial","msid":"","msnumber":"","nonDraftVersions":[{"code":3,"date":"2019-11-21 13:51:17","doi":"10.21203/rs.2.13300/v3","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Accept","date":"2019-11-21T12:00:00+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2019-11-20T12:00:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2019-11-19T12:00:00+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}},{"code":2,"date":"2019-11-12 14:58:36","doi":"10.21203/rs.2.13300/v2","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2019-11-15T12:00:00+00:00","index":1,"fulltext":"Form responses:\n---\n* Level of interest: **An article of importance in its field**\n* Quality of written English: **Acceptable**\n* Quality of figures: **Acceptable**\n* Statistical review: **No, the manuscript does not need to be seen by a statistician**\n* Declaration of competing interests: **I declare that I have no competing interests**\n* Quality of written English\nPlease indicate the quality of language in the manuscript:\tAcceptable: **Quality of figures\nAll images and figures within the manuscript should be genuine i.e. without evidence of manipulation. No specific feature within an image may be enhanced, obscured, moved, removed, or introduced. If you have concerns about the veracity of the figures you should choose the first option below.\tAcceptable**\n"},{"type":"decision","content":"Minor revision","date":"2019-11-15T12:00:00+00:00","index":"","fulltext":""},{"type":"reviewersInvited","content":"","date":"2019-11-13T12:00:00+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2019-11-13T12:00:00+00:00","index":1,"fulltext":""},{"type":"checksComplete","content":"","date":"2019-11-08T12:00:00+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2019-11-08T12:00:00+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}},{"code":1,"date":"2019-08-21 20:17:49","doi":"10.21203/rs.2.13300/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2019-10-07T12:00:00+00:00","index":1,"fulltext":"Form responses:\n---\n* Level of interest: **An article whose findings are important to those with closely related research interests**\n* Quality of written English: **Acceptable**\n* Quality of figures: **Acceptable**\n* Statistical review: **No, the manuscript does not need to be seen by a statistician**\n* Declaration of competing interests: **I declare that I have no competing interests**\n* Quality of written English\nPlease indicate the quality of language in the manuscript:\tAcceptable: **Quality of figures\nAll images and figures within the manuscript should be genuine i.e. without evidence of manipulation. No specific feature within an image may be enhanced, obscured, moved, removed, or introduced. If you have concerns about the veracity of the figures you should choose the first option below.\tAcceptable**\n"},{"type":"decision","content":"Major revision","date":"2019-10-07T12:00:00+00:00","index":"","fulltext":""},{"type":"reviewersInvited","content":"","date":"2019-09-30T12:00:00+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2019-09-30T12:00:00+00:00","index":1,"fulltext":""},{"type":"editorAssigned","content":"","date":"2019-09-23T12:00:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2019-08-17T12:00:00+00:00","index":"","fulltext":""},{"type":"submitted","content":"","date":"2019-08-14T12:00:00+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e294035c-7f57-408d-adc6-7f710bc03c6b","owner":[],"postedDate":"November 21st, 2019","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":35990,"name":"Integrative \u0026 Complementary Medicine"},{"id":35991,"name":"Internal Medicine"},{"id":35992,"name":"Translational Medicine"}],"tags":[],"updatedAt":"","versionOfRecord":{"articleIdentity":"rs-4014","link":"https://doi.org/10.1186/s13063-019-3924-0","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2020-01-06 12:00:00","publishedOnDateReadable":"January 6th, 2020"},"versionCreatedAt":"2019-11-21 13:51:17","video":"","vorDoi":"10.1186/s13063-019-3924-0","vorDoiUrl":"https://doi.org/10.1186/s13063-019-3924-0","workflowStages":[]},"version":"v3","identity":"rs-4014","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"identity":"rs-4014","version":["v3"]},"buildId":"_2-kVJe1T_tPrBINL-cwx","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}