{"paper_id":"44ff849c-f73e-4a00-9835-325d8198c91e","body_text":"1\nLabour Care Guide implementation as a decision-making tool for monitoring labour \namong health care providers in Southwestern Uganda: A protocol for a multisite \nEffectiveness-Implementation study\nMugyenyi GR 1, Mulogo EM 2, Tumuhimbise W 3, AtukundaEC 4 Kayondo M 1, Ngonzi J 1, \nByamugisha J5, Yarine F1\n1Mbarara University of Science and Technology, Department of Obstetrics and Gynaecology\n2Mbarara University of Science and Technology, Department of Community Health\n3Mbarara University of Science and Technology, Department of information Technology\n4Mbarara University of Science and Technology, Department of Pharmacy\n5Makerere University College of Health Sciences\nCorresponding Author: Mugyenyi GR, email: gmugyenyi@must.ac.ug\nMugyenyi GR gmugyenyi@must.ac.ug +256 772 543238\nMulogo EM emulogo@must.ac.ug +256 772433508\nTumuhimbise W twilson@must.ac.ug +256 772 068858\nAtukunda EC eatukunda@must.ac.ug +256 782 949832\nKayondo M mkayondo@must.ac.ug +256 782 407453\nNgonzi J jngonzi@must.ac.ug +256 703818336\nByamugisha J jbyamugisha@gmail.com +256 772 580330\nYarine F gabyfajardot@gmail.com +256 777317195\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \nNOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.\n\n2\nAbstract\nBackground: The new WHO Labour Care Guide, also regarded as the “next-generation \npartograph” basing on recent evidence has been recorded as a core component of the 2018 \nconsolidated set of guidelines on intrapartum care for positive child birth experience. The \nUgandan Ministry of Health is in the process of adopting the new WHO Labour Care Guide \n(LCG) with no local context specific data to inform this transition. This study will employ \nevidence-based research frameworks to identify challenges, and potential opportunities that \nwould inform and refine the implementation strategy and scale-up of this highly promising \nLCG. We will also seek to utilize best practices to evaluate implementation effectiveness of \nthe new LCG, through employing measurable implementation matrices (implementation, \nservice, patient outcomes). \nMethods: This study will be a multisite effectiveness-implementation study across all basic \nand comprehensive emergency obstetric and newborn care facilities in Mbarara district and \nMbarara City in Southwestern Uganda. We will employ both quantitative and qualitative \nmethods to evaluate the use of the newly recommended WHO Labor Care Guide in \nmonitoring labor among all health care providers actively engaged in deliverying women \nacross all public maternity health facilities in Mbarara district and Mbarara City. No \nparticipant has been recruited at hie point in time\nResults and Discussion: This study will offer an opportunity to ascertain whether the new \nWHO Labour Care Guide tool is an effective decision-making tool to monitor labor among \nhealthcare providers conducting routine deliveries in publicly funded facilities in \nSouthwestern Uganda. We will also identify practical, context-specific and actionable \nstrategies for achieving optimal implementation effectiveness in a rural low resource setting. \nKeyword: labour monitoring, obstructed labour, prolonged labour, labour care guide, \ndecision support\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n3\nBackground\nThe global maternal and neonatal death rates are unacceptably high [1-3] and these deaths \nare due to complications of pregnancy and childbirth, mostly from preventable or treatable \ncauses. Most of these deaths (94%) are within low- and middle-income countries and could \nbe prevented through timely interventions. In Uganda, the maternal and neonatal mortality \nremains high at 336 deaths per 100,000 live births and 27 deaths per 1,000 live births \nrespectively [4]. Most maternal deaths in Uganda are linked to prolonged labour; 90% of \nperinatal mortality following birth asphyxia is directly attributed to obstructed labour [5, 6]. \nAdequate labour monitoring,  with early identification of complications and their \nmanagement are vital processes towards improved quality of care, and  averting the \nunfavorable delivery outcomes including fetal, new born and maternal deaths [7].\n \nFriedman’s partograph of 1954, also referred to as the partogram , is a labour progress/ \nmonitoring chart, graphically depicting the dilatation of the cervix or presenting the dilatation \nof the cervix against time in labour (Figure 1). Alert and action lines were later added on \nthis Friedman concept by Philpott and Castle in 1972 and aimed at identifying \ndeviations from normal and guiding users towards early intervention. This partogram has \nbeen  the gold standard for monitoring labour globally [8], and safe motherhood initiatives \nof the 1990s rolled it out as a universal tool for monitoring labour in an effort to \nprevent prolonged and obstructed labour. However, despite decades of health care provider \n(HCP) training, support and investment, rates of partograph utilization, acceptability and \nappropriate use in making critical decisions during labour remain sub optimal \nin resource-limited settings, with correspondingly high incidences of obstructed labour, its \nassociated complications, and ultimately sustained high and unacceptable still birth, maternal, \nand neonatal mortalities [1, 9, 10] [11] [9, 12]. The partogram also offers subjective \nvariations, and assumes that all women progress at same rate, which may affect intervention \nrate [13]. A study of 527 parturients in Southwestern Uganda observed that 77.6% of clinical \nrecords actually contained a partograph, and an abysmal 4.2% had been completed to \n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n4\nstandard [12]. In fact, according to Lugobe and colleagues, the partograph was most \ncommonly used to record birth outcomes and not the actual monitoring of labour which it is \nintended. \nUse of effective evidence-based interventions during labour, childbirth, while avoiding \nineffective or potentially harmful ones could facilitate all women to achieve desired \nemotional, psychological and physical outcomes through regular assessments to identify any \ndeviation from normality (WHO, 2020). With the persistent maternal/perinatal mortalities, \nthe Uganda’s Ministry of Health (MOH) has launched the new Essential Maternal and \nNewborn Clinical Care (EMNC) guidelines for Uganda in which the reproductive health \nexperts recommended replacing the partograph with the new WHO Labor Care Guide (LCG) \n[\n5]. This recommendation was made with anticipation that the new tool was easy to use, \npromptly identifies deviations from normal through regular assessments, encourages \nself-efficacy, stimulates HCP interaction and shared decision making, recognizes \nparticipation of labour companions to promote women centered care, but importantly the \nLCG has been developed for health care providers to identify deviations from normal through \nregular monitoring and assessment of women and their unborn babies. This LCG has been \nencouraged in place of the partograph to monitor the well-being of women and babies during \nlabor to identify any deviation from normality (WHO, 2020). The LCG tool encourages \nhealth care team interaction, and aims at initiating or stimulating interaction among health \nworkers, women and companion/family members, while emphasizing safety, and providing \nevidence based supportive care which has been found to be paramount among expectant \nwomen in our setting (Atukunda et al., 2020), while avoiding unnecessary practices, and \nsolve the sustained challenges that were faced by the HCPs while using the partograph over \nthe decades (user-centered) (WHO, 2020). In fact, according to Vogel and colleagues, this \nnew WHO labour care guide monitoring tool is regarded as the “next-generation” partograph \nincorporating recent effective intrapartum care guidelines [14]. When used properly the LCG \nis thought to effectively detect prolonged labor in time for HCPs to perform required \n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n5\ninterventions in time before progressing to obstructed labor and its sequalae; such as ruptured \nuterus, post-partum hemorrhage, sepsis, maternal and neonatal deaths. For example, while the \npartograph lacked clearly defined identifiers of prolonged/obstructed labour, the new LCG \nidentifies grade three moulding and caput, all represented by +++ , and further defines \nprolonged labour using cervical dilatation specific time lags indicated in its “alert” column of \nsection 5 (Figure 2) as per the new WHO consolidated guidelines on intrapartum care for \npositive childbirth [15]. In fact, the new LCG has alerts for all observations that prompt the \nlabour monitoring team to take action on each abnormal observation as soon as it happens, \nrather than waiting for the plot to reach action line as it is in the partograph.\nUganda’s MOH is in the process of rolling out the implementation of the LCG to all health \nfacilities. However, there is no local context specific data to inform this transition. Many new \ninterventions have failed because of inattention to implementation needs early during their \ndevelopment. This study will employ evidence-based research frameworks to evaluate the \neffectiveness and implementation process of LCG, through employing measurable \nimplementation matrices (implementation, service, patient outcomes). This will help to \nidentify potential opportunities, challenges, inform and refine the implementation strategy \nand scale-up of this highly promising LCG. We will utilize best practices to develop a context \nspecific tool that is aimed at improving end-user (HCPs) acceptability, satisfaction, \nmotivation, appropriateness, feasibility, fidelity, patient-centeredness and effectiveness of this \nnew tool in monitoring labour progress in a rural Southwestern Ugandan community setting \nwhere the impact of such an intervention is likely to be the greatest. \nMethods\nStudy design\nWe shall conduct a mixed method multisite effectiveness-implementation study across public \nhealth facilities in Mbarara district and Mbarara City -Southwestern Uganda to refine the \nnewly recommended WHO Labor Care Guide in monitoring labor during routine care and \nevaluate its effectiveness and implementation using Proctor’s implementation outcomes \n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n6\nframework  as outlined in Table 1. We hypothesize that the modified LCG will improve \nlabour monitoring, reduce prolonged labour, obstructed labour, its complication, ultimately \nreducing the maternal and neonatal deaths. The proposed interviews will help to refine \nimplementation strategies for scale-up using the Consolidated Framework for Implementation \nResearch (CFIR) as outlined in Table 2. Our outcomes will also serve as indicators of \nimplementation success or necessary pre-conditions for attaining desired service outcomes \nfor HCPs carrying out deliveries in rural, resource-limited settings. \nWe will utilize an ambispective cohort; a combination of a historical cohort of mothers \nmonitored using a partograph and prospective cohort of women monitored using the new tool \nto evaluate implementation success (effectiveness). As a concerted effort to meaningfully \nimplement a new intervention meant to reduce preventable maternal and perinatal morbidity \nand mortality, these results will generate grounded, robust scientific data to inform \nstakeholders and policy makers working towards effectively integrating and scaling up of this \nnew LCG into routine maternity care in similar settings across the country and beyond. This \nstudy will also be able to show the effect of this intervention, and optimize its implementation \nin routine maternity care practice to improve maternal-fetal outcomes in similar settings. No \nparticipant has been recruited at hie point in time\nStudy setting\nThe study will be carried out in all public health facilities offering basic and comprehensive \nemergency obstetric and newborn care in Mbarara district and Mbarara City. These include \nall 11 public Health center threes (HCIII), two Health Center fours (HCIV) (Bwizibwera, \nMbarara City Council ), and one regional referral Hospital (Mbarara Regional Referral \nHospital (MRRH). Mbarara District is located approximately 270 kilometers Southwest of \nthe capital, Kampala, with a population of abount 250,000 people distributed through two \nrecent administrative units of Mbarara City and Mbarara district. Uganda’s public health \nsystem is organized into seven tiers with national and regional referral hospitals, general \n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n7\ndistrict hospitals and four levels of community health centers. Staffing and available services \nvary across the four levels: HCIII offer basic emergency obstetric care (carry out ANC and \nconduct vaginal deliveries), whereas Health Center one (HCI) and Health Center two (HCII) \nserve as low resource primary health care units. HCIVs and hospitals conduct normal and \ncaesarean deliveries (offer comprehensive emergency obstetric care), and have ambulances \nand blood transfusion services [16]. Private providers operate in parallel to the public health \nsystem to provide maternal health care. Basic and emergency obstetric care services are \nprovided through four hospitals; Mbarara Regional Referral Hospital and four privately \nowned; Divine Mercy Hospital, Ruharo mission Hospital, Mbarara Community Hospital, \nMayanja Memorial Hospital, and with two HC IVs of Bwizibwera and Mbarara City. \nMbarara is served by 11 HC IIIs, and over 40 privately-owned health facilities that provide \nmaternity services. The district is served with a total of 253 HCPs who provide obstetric \nhealth care with a large concentration at Mbarara Regional Referal Hospital and the health \ncenter IVs (2 medical officers and 10 midwives on average) [17].\nThe local economy of the districts is largely based on subsistence agriculture, with both food \nand water insecurity being common [18]; ANC attendance of ≥4 visits is still at 58%, and \nmaternity services, including delivery, are largely provided free of charge. The study will be \nconducted at the labour suite and post-natal wards of all the 11 HCIIIs,  ( 6 from Mbarara \ndistrict including Bubaare, Bukiro, Kagongi, Kashare, Rubaya and Rubindi distributed in the \n6 subcounties of Mbarara District and 5 HCIIIs of Biharwe, Kakoba, Nyakayojo, Nyamitanga \nand Kyarwabuganda distributed in the 6 didvision of Mbarara City plus 2 HCIVs (of \nBwizibwera and Mbarara City) and Mbarara Regional Referral Hospital. All mothers in \nlabour are ideally monitored using a partogram and the fetal heart rate is measured manually \nper clinician judgment using the Pinard. After a normal (un complicated) vaginal delivery,  \nthe mothers from these facilities with their babies are admitted to the post-natal wards for 24 \nhours, with daily ward rounds conducted by skilled birth attendants. Those who deliver by \ncaesarean section remain admitted for 3 to 5 days though mothers and babies with \ncomplications are admitted for more days.\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n8\nStudy population\nAll adult HCPs actively involved in maternity care and conducting deliveries, health facility \nmanagers in Mbarara district and officials from the reproductive health division of the \nUgandan Ministry of Health will be included in this study. The principal investigator will \nprovide a list of these eligible HCPs to the study research assistants, who will then contact \nand seek written informed consent before enrolment into the study. HCPs will be taken \nthrough the study procedures. Eligible local and national MOH facility \nmanagers/stakeholders who participate in budgeting, procurements or funding for facilities \nwill also be identified and enrolled into the study. \nEligibility Criteria\nIndividuals with self-reported willingness to use the new LCG in monitoring of labour, able \nand willing to provide informed consent will be invited to participate in this study. \nIndividuals unwilling to use the LCG and unable to provide informed consent will not be \neligible to participate in this study.\nStudy procedure \nWe will carry out baseline needs assessment among HCPs who actively engage in \ndeliverying women in Mbarara district and Mbarara City for a period of atleast 1 year before \nthe introduction of the LCG. Guided by the Consolidated Framework for Implementation \nResearch CFIR [19], we will first identify unique needs, challenges, facilitators and patterns  \nof potential and sustained uptake of the new intervention (LCG) at different levels of the ‘4 \ntier’ health system to monitor labour in rural Southwestern Uganda (Aim 1). This will \ninvolve conducting in-depth qualitative interviews with up to 30 purposively selected HCPs, \nand 15 Ugandan MoH officials at the onset of the study. We will then characterize, and refine \nthe new WHO LCG based on the findings from Aim 1, and then develop a suitable \nimplementation strategy to effectively integrate the new LCG into routine maternity care in \nMbarara district and city. We will iteratively test the LCG prototype amongst three sets of 10 \nHCP users (interviewed from objective 1). The aim is to refine and customize the tool for \neasy uptake and sustained utilization within a known intervention development framework \n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n9\n[20-22]. Ten women in three successive iterations will be involved to test subsequent \nprototypes. Upon completion of each of the one-week period, we will interview HCPs using \nstructured questionnaires to obtain feedback on the ease of use, complexity, content, tool’s \nability to engage, motivate, prepare, request or get support/attention as needed, cues to \naction/alerts/prompts, social support, guidance on what to do at each stage for optimal and \ntimely response. After each iterative round, we will hold group discussions at the local and \nMOH level to explore user experiences, define and refine relevant components of the LCG. \nThe final LCG prototype will be ready for evaluation in routine care on a bigger scale \n(Mbarara district and Mbarara city health facilities).We will also customize the existing \ntraining manuals developed by WHO to suite within the local Ugandan context using this \nfeedback. This is aimed at improving the skill, ease-of-use, and appropriate utilization of the \ndeveloped LCG to maximize impact. Training on LCG use will generally aim at behavioral \nchange communication; reference information and foot notes will be integrated within the \nlabor care guide prints to facilitate exposure, awareness, accurate delivery, usability, \ncomprehension and decision making [20].\nOnce the refined prototype is completed, we will evaluate the LCG use by HCPs conducting \ndeliveries from all basic and comprehensive emergency obstetric and new born care facilities \nof Mbarara district and Mbarara City. We will utilize the Proctor implementation outcome \nframework (Table 2) to evaluate implementation outcomes of using the new labour care \nguide in routine maternity care that include; acceptability, appropriateness, feasibility, fidelity, \nand effectiveness among HCPs actively involved in deliveries across Mbarara District and \nMbarara City. A data abstraction tool for women who were monitored using the partograph \n(historical cohort) and prospective data for those monitored using the new LCG will be \ndesigned and used in the document review to collect data from patient facility records. We \nwill design a database and enter all partograph and LCG abstracted data. We will document \nand assess delivery outcomes (effectiveness) such as duration of active phase of labor, \nduration of second stage of labor, presence of labor companion, initiation of breastfeeding \nand other relevant maternal-fetal outcome events as described in the data collection section. \n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n10\nA chart review of the files and or postnatal discharge forms will also be done to document \ntool completion, as well as actual labour and delivery outcomes \nFinally, we will assess the diagnostic predictability of the new LCG compared to the \npartogram in effectively detecting prolonged labour and reduce rates of obstructed labour \namong women delivering in Mbarara district and Mbarara City. We will use the effectiveness \ndata to assess the specificity, sensitivity, negative and positive predictive values  of the new \nLCG versus partogram as the presumed standard of care. Because the key identifiers of \nobstructed labour were not clearly defined and indicated on the previous partogram, namely \ngrade 3 moulding and caput, we will use prolonged labour as a quantifiable comparative \nmeasure. Prolonged labour will be defined using a partogram as labour progress that crossed \nthe action line figure 1), and cervical dilatation specific time lags indicated in the “alert” \ncolumn when using  the LCG. Whereas prolonged labour was defined at the end as labour \ncrossing the action line on the partograph with no ongoing prompts in between, the new LCG \nrecommends on going practical observable “time lag” at each specific centimeter of cervical \ndilation as specifiied in the “alert” column of section 5 which empowers HCP to make \ndecisions before obstructed labour develops, indicated by grade 3 moulding/caput in section 3 \nof the new LCG .\nWe will summarize the clinical and demographic data obtained from document review of the \npatients in the ambispective cohort. We will then assess the diagnostic validity of the new \nLCG versus the partogram as the presumed standard of care. To describe the performance of \nthe LCG compared to the partogram, we will consider prolonged labor as a dichotomus \noutcome to asses the specificity and sensitivity of the LCG, and fit a receiver operating curve \nat different time points from 4 centimetre cervical dilatation (for partograph) and 5 centimeter \ncervical (for the new LCG) till vaginal delivery or decision to perform caesarean section. \nOutcomes \nThe primary effectiveness outcome will be the proportion of women with prolonged labour. \n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n11\nWe will define prolonged labour as 1) labour crossing the action line on the partograph,  2) \nlabour lasting more than a specified centimeter cervical dilation “time lag” in the alert \ncolumn of section 5 of the LCG. \nSecondary outcomes will include; proportion of obstetric interventions such as caesarean \nsections, labour augmentation, blood transfusion; quality-of-care; having a fresh still birth; \nduration of 1 st and 2 nd stages of labor; 5-minute apgar score, need for rescuscitation/blood \ntransfusion, mode of delivery; initiation of breastfeeding; obstetric complications diagnosed \nand or managed during labor, childbirth or immediate postpartum; ruptured uterus; \npostpartum hemorrhage; maternal/newborn sepsis; maternal, fetal, and newborn deaths.\nPower and sample size calculations \nThis study will enrol all HCPs actively engaged in delivering women across public facilities \noffering basic and comprehensive obstetric care across Mbarara district. Current statistics \nindicate a 2% of obstructed labor, and 21% of obstructed labor complications [23]. \nConsequently, Uganda suffers from one of the highest maternal mortality ratios (336 for \nevery 100,000 women), and child perinatal mortality rates (41 deaths per 1000 births) in the \nworld. The study team will review all the documents one year before and one year after \nimplementation of the LCG to assess effectiveness and implementation success. As we move \nthe LCG to a community setting with more users, subject to local public health facility \nchallenges, uptake, utilization, and training needs may vary [24]. A 10% reduction would \ntherefore be meaningful for policy makers to signify public health importance, and in \ndemonstrating an improved maternal-newborn outcomes at the local community level. Since \nwe are enrolling and reviewing all documents/files, we will have sufficient power to detect \nsecondary maternal-newborn outcomes that would be more informative for maternal health \npolicy makers and implementers. We will therefore have sufficient power to detect a \nprogrammatically meaningful 10% superiority reduction rate of prolonged labour/obstructed \nlabour from over 20,000 deliveries recorded across Mbarara district and Mbarara city \nannually after implementation of the LCG.\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n12\nData collection and Management \nThe demographic and clinical data will be collected from maternity records of women that \nhave delivered within one year before and a year after implementation of the LCG including; \npatient demographics (e.g age, gravidity, parity, gestational age), prenatal, antepartum \nhigh-risk morbidities, non communicable diseases (NCDs), and HCP demographics; age, \neducation, experience, self-efficancy. All data will be entered into REDCap and checked for \ncompleteness and quality by the principal investigator and any problems that arise will be \nresolved immediately.\nCharts of women whose labour was monitored using a partograph one year before \nintroduction of the new WHO LCG  will constitute a partogragh-historical cohort (control \narm) while those monitored using the new LCG will form the prospective LCG (intervention \narm) of the study. We will first summarize health-related and socio-demographic data \nbetween arms. For our primary effectiveness outcomes, we will fit a multivariable logistic \nregression model, with study arm as the predictor of interest, and age, high-risk pregnancy \nand health facility at enrollment as a priori additional variables in the model, due to their \nstrong association with the selected outcome[25-27]. Although not designed to detect a \ndifference, we will also explore additional secondary outcomes, as listed above. We will also \nsummarize implementation outcomes for the new LCG users (HCPs) using descriptive \nstatistics. Success in the implementation survey data will be identified qualitatively and by \nthe top tertile of relevant scales (e.g., acceptability, feasibility, satisfaction, appropriateness). \nWe will also describe the ranked implementation strategies selected by LCG users and key \nMOH stakeholders observed during the feedback interviews. Lastly, we will calculate the \npositive and negative predictive values of prolonged labour, and summarize it in relation to \nthe calculated prevalence, as well as the documented prevalence in Uganda. Data analysis \nwill be conducted using STATA version 17 (Statacorp, College Station, Texas, USA). \nFindings will be presented as descriptive statistics, scatter plots and graphs; statistical \nsignificance will be considered at p ≤ 0.05.\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n13\nQualitative analysis\nAll transcripts from the interviews will be done and transcribed in English by two research \nassistants. The aim of this analysis will be to inductively construct categories describing \nmultilevel factors and strategies that might influence LCG implementation and effectiveness. \nQualitative analysis will be inductive, and a codebook will be developed through \nconventional content analysis [28]. To ensure accuracy, transcripts will be coded to calculate \nan intercoder reliability Kappa statistic using the NVIVO software Version 12 (Melbourne, \nAustralia). We will begin the category construction process with repeated review of \ntranscripts to identify relevant content. Identified content will serve as the basis for \ndeveloping a coding scheme. Coded data will be iteratively reviewed and sorted to suggest \ncategories under the general headings as per the employed CFIR framework. The categories \ndeveloped from coded data will consist of descriptive labels, elaborating text to define and \nspecify each category’s meaning, and illustrative quotes taken from the qualitative data. \nDemographic data will be used to describe the sample.\nEthical considerations\nEthical clearance was obtained from the Faculty Research Committee (FRC) in the faculty of \nMedicine and the Research Ethics committee (REC) (Protocol number: MUST-2023-808) at \nMbarara University of Science and Technology. Study site administrative permission was \nobtained from Mbarara Regional Referral Hospital, Mbarara District Health officer and the \nCity Health Officer for Mbarara City. We obtained approval from the National Council for \nScience and Technology in Uganda and will obtain written informed consent from all study \nparticipants before enrolment in the study.\nPublication and dissemination of results\nThe research outcomes from this study will be published in international peer reviewed open \naccess journals and the Ugandan Ministry of Health, and selected national and international \nconferences. The study will be registered with clinicaltrials.gov.\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n14\nDiscussion\nThis study offers an opportunity to ascertain whether the new LCG tool is an effective \ndecision-making tool to monitor labor among obstetric care providers in publicly funded \nfacilities in rural settings such as Uganda. The WHO LCG has been referred to as a \n“next-generation” partograph for HCPs in adequately monitoring the well-being of women \nand babies during labour and childbirth, timely identifying any deviation from normal and \nfacilitating HCP interaction, stimulate shared decision-making for HCPs, laboring women \nand their companions/family thus facilitating timely management, quality of women-centered \ncare and birthing experience. The tool aims toThe reference thresholds for abnormal labour \nobservations (for each monitored parameter) provided by the new LCG are meant to trigger \nspecific actions, and thus targets to minimizeover-diagnosis and under-diagnosis of abnormal \nlabour events and the unnecessary use of interventions such as caesarean sections and \naugmentation. \nLimitations \nThis study will be conducted at a time when the Ugandan MOH will be recalling the use of a \npartogram and with some isolated facilities already using  the original WHO LCG. We will \ntherefore be unable to conduct a well-controlled prospective cohort using the obsolete \npartograph, hence our choice to utilize a historical or retrospective cohort of partograph data \nto conduct this study. While we may find more  missing data in the partograms for the \nretrospective partograph arm, we have powered the study to deal with the missing data and \nentering data from all available partographs at the facilities for a whole year proceeding the \nnew LCG introduction. However, in sensitivity analyses, we will repeat the analysis after \nexcluding women with missing outcome data. \n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n15\nImplication to policy makers and implementers\nNo rigorous adoption and evaluation of the effectiveness and implementation of the new \nWHO LCG intervention has been conducted in Uganda or similar setting to inform \nstakeholders on successful roll out of the intervention on a large scale, and long term. The \nUgandan Ministry of Health is in the process of adopting the new WHO LCG with no local \ncontext specific data to inform this adoption and transition for use in routine care. This study \ntherefore seeks to utilize best practices to support intervention adoption, uptake, \nimplementation, integration and scale up. This study will offer an opportunity to ascertain \nwhether the new WHO Labour Care Guide tool is an effective decision-making tool to \nmonitor labor among healthcare providers conducting routine deliveries in publicly funded \nfacilities in Southwestern Uganda. We will also identify practical, context-specific and \nactionable strategies for achieving optimal implementation effectiveness in a rural low \nresource setting.  This study has potential to prevent a substantial number of annual 823,000 \nstillbirths, 1,145,000 neonatal deaths and 166,000 maternal deaths in the 75 highest burden \ncountries [29-32].\nReferences\n1. WHO, Trends in maternal mortality 2000 to 2017: estimates by WHO, UNICEF, \nUNFPA, World Bank Group and the United Nations Population Division. 2019.\n2. Say, L., et al., Global causes of maternal death: a WHO systematic analysis. The \nLancet global health, 2014. 2(6): p. e323-e333.\n3. Leisher, S.H., et al., Seeking order amidst chaos: a systematic review of classification \nsystems for causes of stillbirth and neonatal death, 2009–2014. BMC pregnancy and \nchildbirth, 2016. 16: p. 1-17.\n4. Atukunda, E.C., et al., Measuring post-partum haemorrhage in low-resource settings: \nthe diagnostic validity of weighed blood loss versus quantitative changes in \nhemoglobin. PloS one, 2016. 11(4): p. e0152408.\n5. MOH, Essential Maternal and Newborn Clinical Care Guidelines for Uganda.  2022.\n6. Musaba, M.W., et al., Risk factors for obstructed labour in Eastern Uganda: A case \ncontrol study. PLOS ONE, 2020. 15(2): p. e0228856.\n7. Heazell, A.E., et al., Stillbirths: economic and psychosocial consequences.  The Lancet, \n2016. 387(10018): p. 604-616.\n8. Dalal, A.R. and A.C. Purandare, The partograph in childbirth: an absolute essentiality \nor a mere exercise?  The Journal of Obstetrics and Gynecology of India, 2018. 68: p. \n3-14.\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n16\n9. Wakgari, N., et al., Partograph utilization and associated factors among obstetric \ncare providers in North Shoa Zone, Central Ethiopia: a cross sectional study.  African \nhealth sciences, 2015. 15(2): p. 552-559.\n10. Haile, Y., et al., Partograph utilization and associated factors among obstetric care \nproviders at public health facilities in Hadiya Zone, Southern Ethiopia. Journal of \nPregnancy, 2020. 2020.\n11. Mezmur, H., A. Semahegn, and B.S. Tegegne, Health professional’s knowledge and \nuse of the partograph in public health institutions in eastern Ethiopia: a \ncross-sectional study. BMC pregnancy and childbirth, 2017. 17: p. 1-7.\n12. Lugobe, H.M., et al., Older age and higher parity are associated with nonuse of the \npartograph at Mbarara Regional Referral Hospital, Uganda.  International Journal of \nGynecology & Obstetrics, 2019. 146(3): p. 321-325.\n13. Zelellw, D.A. and T.K. Tegegne, Level of partograph utilization and its associated \nfactors among obstetric caregivers at public health facilities in East Gojam Zone, \nNorthwest Ethiopia. PloS one, 2018. 13(7): p. e0200479.\n14. Vogel, J.P., et al., Usability, acceptability, and feasibility of the World Health \nOrganization Labour Care Guide: A mixed-methods, multicountry evaluation.  Birth, \n2021. 48(1): p. 66-75.\n15. WHO, WHO recommendations on intrapartum care for a positive childbirth \nexperience. 2018: World Health Organization.\n16. Mbonye, A.K., et al., Emergency obstetric care as the priority intervention to reduce \nmaternal mortality in Uganda. International Journal of Gynecology & Obstetrics, \n2007. 96(3): p. 220-225.\n17. Government, M.D.L., Annual Work plan 2022/23: Bwizibwera HC IV . 2022.\n18. Tsai, A.C., et al., Food insecurity, depression and the modifying role of social support \namong people living with HIV/AIDS in rural Uganda.  Soc Sci Med, 2012. 74(12): p. \n2012-9.\n19. Damschroder, L.J., et al., Fostering implementation of health services research \nfindings into practice: a consolidated framework for advancing implementation \nscience. Implementation science, 2009. 4(1): p. 1-15.\n20. Holden, R.J. and B.T. Karsh, The technology acceptance model: its past and its future \nin health care. J Biomed Inform, 2010. 43(1): p. 159-72.\n21. Campbell, M., et al., Framework for design and evaluation of complex interventions \nto improve health. BMJ, 2000. 321(7262): p. 694-6.\n22. Bendixen, R.M., et al., A User-Centered Approach: Understanding Client and \nCaregiver Needs and Preferences in the Development of mHealth Apps for \nSelf-Management. JMIR Mhealth Uhealth, 2017. 5(9): p. e141.\n23. ICF., U.B.o.S.U.a., Uganda  Demographic  and Health  Survey  2016:  Key \nIndicators Report. 2017: Kampala, Uganda: UBOS, and R\nockville, Maryland, USA: UBOS and\n ICF. .\n24. Glasgow, R.E., E.T. Eckstein, and M.K. Elzarrad, Implementation science perspectives \n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n17\nand opportunities for HIV/AIDS research: integrating science, practice, and policy.  J \nAcquir Immune Defic Syndr, 2013. 63 Suppl 1: p. S26-31.\n25. Atukunda, E.C., et al., Sublingual misoprostol versus intramuscular oxytocin for \nprevention of postpartum hemorrhage in Uganda: a double-blind randomized \nnon-inferiority trial. PLoS medicine, 2014. 11(11): p. e1001752.\n26. Kajabwangu, R., et al., Factors associated with delayed onset of active labor following \nvaginal misoprostol administration among women at Mbarara Regional Referral \nHospital, Uganda. International Journal of Gynecology & Obstetrics, 2021. 153(2): p. \n268-272.\n27. Ngonzi, J., et al., Puerperal sepsis, the leading cause of maternal deaths at a Tertiary \nUniversity Teaching Hospital in Uganda. BMC Pregnancy and Childbirth, 2016. 16(1): \np. 207.\n28. Hsieh, H.F. and S.E. Shannon, Three approaches to qualitative content analysis.  Qual \nHealth Res, 2005. 15(9): p. 1277-88.\n29. Leisher, S.H., et al., Seeking order amidst chaos: a systematic review of classification \nsystems for causes of stillbirth and neonatal death, 2009-2014. BMC Pregnancy \nChildbirth, 2016. 16(1): p. 295.\n30. Lawn, J.E., et al., Stillbirths: rates, risk factors, and acceleration towards 2030. Lancet, \n2016. 387(10018): p. 587-603.\n31. Heazell, A.E., et al., Stillbirths: economic and psychosocial consequences.  Lancet, \n2016. 387(10018): p. 604-16.\n32. WHO/UNICEF, REACHING THE EVERY NEWBORN NATIONAL 2020 MILESTONES: \nCOUNTRY PROGRESS, PLANS AND MOVING FORWARD. 2017, World Health \nOrganisation: Geneva.\n33. Weiner, B.J., et al., Psychometric assessment of three newly developed \nimplementation outcome measures. Implement Sci, 2017. 12(1): p. 108.\n34. Weiner, B.J., et al., Psychometric assessment of three newly developed \nimplementation outcome measures. Implementation Science, 2017. 12(1): p. 108.\n35. Larsen, D.L., et al., Assessment of client/patient satisfaction: development of a \ngeneral scale. Eval Program Plann, 1979. 2(3): p. 197-207.\n36. Gary R. Bond, Ph.D. ,, et al., Validation of the Revised Individual Placement and \nSupport Fidelity Scale (IPS-25). Psychiatric Services, 2012. 63(8): p. 758-763.\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint \n\n . CC-BY 4.0 International licenseIt is made available under a \n is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review)\nThe copyright holder for this preprint this version posted June 7, 2023. ; https://doi.org/10.1101/2023.06.06.23291028doi: medRxiv preprint","source_license":"CC-BY-4.0","license_restricted":false}