Effectiveness of Community Engagement Using M-Mama Champions in Improving Literacy of Obstetric Danger Signs, Birth Preparedness and Complication Readiness Among Pregnant Women in Bahi, Dodoma. A Community-Based, Cluster Randomized Controlled Trial

Effectiveness of Community Engagement Using M-Mama Champions in Improving Literacy of Obstetric Danger Signs, Birth Preparedness and Complication Readiness Among Pregnant Women in Bahi, Dodoma. 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A Community-Based, Cluster Randomized Controlled Trial Alex Sanga, Stephen Kibusi, James Tumaini Kengia This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4147830/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background : Maternal mortality remains a global public health issue, Sustainable Development Goal 3 targets to reduce it to less than 70 for every 100,000 live births by 2030. Maternal mortality whose peak is during intrapartum and the first day post-partum, 75% of it is accounted for by obstetric danger signs complications. Tanzania’s maternal mortality ratio stands at 104 for every 100,000 live births higher than the SDG target. Innovations that include M-MAMA Champions as facilitators in women groups are necessary to improve the literacy level of obstetric danger signs, birth preparedness, and complication readiness among pregnant women and enhance obstetric emergency response and service utilization, for essential interventions in healthcare facilities alone haven’t been able to reduce maternal mortality due to poor services utilization. Methods: In a community-based, parallel-group cluster randomized controlled trial (cRCT) design, a total of 120 first and second-trimester pregnant women will be randomized at a ratio of 1:1 to the intervention and control groups. The sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm will be done for a period of one month, each two-hour session will be delivered in an interval of two weeks, using participatory learning and action model. The effect of the intervention will be determined using repeated ANOVA analysis, of which the effect of M-MAMA Champions on literacy level and practice between arms will be determined. Discussion; Implementation fidelity of the intervention will be ensured through implementation observation by the researcher, research assistants, and the community health workers. Ethics approval and consent to participate ; The University of Dodoma Research Ethics Committee approved this study (Ref. No. MA.84/261/02/1/115). The study will ensure the protection of the participants’ values, dignity, and integrity per the Helsinki Declaration by the World Medical Association. Obstetric Danger Signs Birth Preparedness and Complication Readiness M-MAMA Champion Participatory Learning and Action Women Groups Figures Figure 1 Introduction Maternal mortality remains a global public health issue, despite the global initiative to reduce it to meet the targets under Sustainable Development Goal 3, which envisages reducing it to less than 70 for every 100,000 live births by 2030 globally( 1 ). Maternal mortality commonly occurs during intrapartum and the first day post-partum( 2 ) and Obstetric danger signs account for more than 75% of all obstetric complications leading to maternal deaths( 3 , 4 ). However, there is still low knowledge of obstetric danger signs, birth preparedness, and complication readiness and their practice among pregnant women, which plays a significant role in the slow pace of maternal mortality reduction( 5 ). The global average of maternal mortality ratio is 256 per 100,000 live births, which is equivalent to 810 maternal deaths occurring due to pregnancy and childbirth-related complications daily( 6 ). Tanzania’s maternal mortality ratio is estimated to be 104 per 100,000 live births( 7 ), which is still higher than the SDG target to be attained by 2030( 1 ). Therefore, innovations that are community-based like M-MAMA referral and emergency systems are necessary to address the second delay as an attribute of maternal mortality, in Tanzania( 8 – 10 ). The majority of maternal deaths occur in Sub-Saharan Africa, which accounted for two-thirds of global maternal deaths in 2017( 6 ). Through a three-delay model, three factors contribute to maternal mortality, delay in deciding to seek care, access a health facility, and receive optimal care once one has arrived at a health facility for definitive care( 11 ). Maternal mortality as a good indicator of the utilization of health services( 2 ) is undeniably a terrible injustice for it leads to several detrimental impacts on families and family members' physical and mental health. It is therefore crucial that the maternal mortality rate is reduced to the lowest possible figures to avoid those negative effects( 6 ). The low knowledge of obstetric danger signs among couples especially those with low literacy ( 12 , 13 ) is among the factors that leads to the first delay which ultimately leads to maternal mortality. It’s essential to help the couples prepare in advance for childbirth and make prompt decisions in case of obstetric emergencies for such interventions targeting the first delay, work in tandem with interventions targeting the second and third delays( 14 – 16 ). This is justified by the high coverage of essential interventions in healthcare facilities haven’t been able to reduce maternal mortality due to poor service utilization. Lack of knowledge of the importance of seeking medical attention during pregnancy and labour among pregnant women negatively influences health behaviour and decision-making processes( 2 ). Empowering women with knowledge of Obstetric Danger Sings (ODS) ensures that they are capable of taking ownership of the decisions about their care at the right time without relying on others to make decisions for them. Community-based interventions have shown to contribute significantly in reducing maternal mortality, especially in rural settings ( 17 , 18 ). This includes the training of community health extension workers to recognize obstetric danger signs in pregnancy and make prompt decisions to seek care. Women groups have also been determined to be very effective ( 2 ). Women groups are utilized for learning through participatory learning and action (PLA) ( 17 ), comprising four phases: identification and prioritization of maternal problems, planning for locally feasible solutions, implementation and assessment, through stories, games, and pictures to discuss prevention, care seeking and treatment for common maternal problems( 2 ) with 88% reduction of maternal deaths ( 17 ). M-MAMA Champions, are designed to provide health education in the form of women groups coupled with their experience from M-MAMA referral and emergency services to potentiate the positive gains from the program in all the regions in Tanzania. This will ensure that knowledge on obstetric danger signs among pregnant women is enhanced and contribute towards birth preparedness and complication readiness that ultimately contributes to maternal mortality reduction ( 15 , 19 ). M-MAMA Referral and Emergency System M-MAMA referral and emergency system is a local initiative developed in Tanzania by development partners (Touch Foundation, PATHFINDER) in collaboration with the health sector (Ministry of Health and President’s Office regional administration and local government), funded by Vodafone Foundation and the Government of Tanzania, aiming at improving maternal health through mobile services (Mobile maternal health – M-MAMA) in the country. The pilot results from Shinyanga, Buchosa, and Sengerema councils, from 2013 to 2017, lead to the scale up of the program from 2022 in all the regions in Tanzania mainland and Zanzibar Island. The M-MAMA program inception targets maternal mortality reduction through devised strategies according to the three-delay framework. The devised interventions for each delay phase include community awareness creation through Community health workers (CHWs) to empower the community with knowledge on obstetric emergencies, advocate for the newly introduced services, promote the use of a toll-free number (115), and create service utilization demand. Utilization of the available ambulances for emergency transportation, and in case an Ambulance is not available, the identified, trained, and contracted community taxi drivers for the emergency transportation to avoid the second delay from both community-to-facility and interfacility transport. The program operational costs are carried out by the Government of the United Republic of Tanzania for sustainability. In the pilot, the program has been determined to be cost-effective in shortening the second delay compared to routine ambulance use ( 9 ), whereby maternal mortality declined by 70% within two years. Also, the program trained healthcare workers on proper management of obstetric emergencies, renovated healthcare facilities, specifically the operating theaters, and supplied equipment and supplies to the referral facilities which provided comprehensive or basic emergency obstetric and neonatal care (CEmONC or BEmONC) to avoid third delay. The program established Dispatch centers, stationed at either the regional referral hospital or the selected council hospitals, each equipped with a human resource (locally available), remote triage tablet, and a mobile phone with a toll-free number for communication. The emergency response process is envisaged to be initiated by either the community or the lower-level healthcare facility through a call. However, during the scale-up of the program to the rest of the regions, some interventions were dropped including the community awareness creation that was left to be addressed by other programs through government efforts or other funding opportunities by other development or implementing partners. Aim of the study This study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness and Complication Readiness among Pregnant Women in Bahi, Dodoma. The specific objectives are. To determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs among pregnant women. To determine the effectiveness of community engagement using M-MAMA Champions on awareness of birth preparedness and complication readiness among pregnant women. To determine the effectiveness of community engagement using M-MAMA Champions on the practice of birth preparedness and complication readiness among pregnant women. Research Hypothesis Null Hypothesis ; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches like CHWs/HCWs. Alternative hypothesis; Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness and Complication Readiness among Pregnant Women is more effective than routine approaches like CHWs/HCWs. Operational definitions M-MAMA referral and emergency system refer to the systems that transport pregnant women from either community or lower to the higher-level facilities for definitive care, to reduce second delay, attributed to maternal death. M-MAMA Champions refers to the mothers who have received the M-MAMA referral and emergency services during their previous delivery, are ready and willing to empower other pregnant women, residing in the communities where the study will be conducted. Community engagement using M-MAMA Champions refers to the utilization of women who are the beneficiaries of the M-MAMA program to mobilize pregnant women in their localities to create awareness and improve their knowledge on obstetric danger signs, birth preparedness and complication readiness in the form of women groups, whereby the M-MAMA Champions act as facilitators within the groups. Methods Study Setting; The study will be conducted in Bahi, Dodoma. Dodoma is Tanzania’s capital city located in the central zone and borders Morogoro to the east, Iringa to the south, Singida to the west, and Manyara to the North. Dodoma region has 3,085,625 people, of which nearly 10% (322,526) constitute the population residing in the Bahi council ( 20 ). Dodoma region is one of the regions with the highest maternal mortality rate in the country estimated to be 417 per 100,000 live births ( 21 ), while Bahi District Council maternal mortality ratio (MMR) is estimated to be 400 deaths per 100,000 births, that makes it the second council with the high MMR among the councils of Dodoma region ( 22 ). Study Design; A parallel group, Cluster randomized controlled trial (cRCT) study design will be used for this study, whereby the Obstetric danger signs (ODS), birth preparedness, and complication readiness (BP & CR) sensitization intervention will be provided in clusters that will randomly be assigned to the intervention arm. The clusters are designed at the village or street level. The sensitization will be provided by the M-MAMA Champions after being empowered on the adapted training package. The M-MAMA Champions will be identified within the intervention clusters through the M-MAMA database and health facility registries of post-natal mothers who will have benefited from the program about their address to determine their location as per the cluster allocated. M-MAMA Champions as a group being tested for sensitization on obstetric danger signs, birth preparedness, and complication readiness in their respective communities have been targeted as a potential group to have benefited from the M-MAMA services thence will be resourceful to empower other pregnant women on ODS, BP & CR and narrate their experiences and benefits they obtained from the program when those danger signs were noted to enhance understanding and practice of birth preparedness and complication readiness. The engagement will be done through participatory learning and action, whereby the M-MAMA Champions will play a role of facilitators. The clusters that will randomly be assigned to the control group won’t receive any intervention. Schematic diagrammatic schedule indicating the steps to be followed during the implementation of the research is as stipulated in Fig. 1 . Recruitment and Training of M-Mama Champions Recruitment; The M-MAMA Champions will be identified and recruited from clusters that will be randomized to the intervention arm. The exact source of M-MAMA Champions will be the M-MAMA database which is housed at the President’s Office of Regional Administration and Local Government and the health facilities in the respective clusters. The database contains the client’s details of the referring and receiving health facilities to which the client attended and the date of the referral. It is presumed, that the contact details will be obtained at the referring health facility through health facility records. The inclusion criteria of M-MAMA Champions , those aged 15 to 49 years, at least 3 months post-delivery, primary education, ready, and volunteering to empower other women ( 23 ). The selected M-MAMA Champions will be contacted via phone call and requested to participate in the study, followed by physical contact, whereby the consent form will be presented for them to sign. It will then be followed by the collective orientation of the package to be used for empowering pregnant women with knowledge of obstetric danger signs, birth preparedness, and complication readiness ( 24 ). A simple random selection of three ( 3 ) M-MAMA Champions per cluster will be done, among those who will have attained a minimum competence score after the orientation. Training Package Customization; The Tanzania Ministry of Health package or module on basics of reproductive, maternal, new-born, child, and adolescent health for community health workers, which contains 18 sessions will be adapted and customized based on the study requirements (ODS, BP &CR) to suit the intended intervention to the target population. The package will be customized through an extraction of the specific sessions; whereby other unintended contents won’t be included. It will be followed by the review of the newly customized package by the experts for comments, which will be worked up accordingly. The proposed package will be translated into Kiswahili, which will also be reviewed by the experts for comments on the understanding, language of the target group, and the friendliness to the readers, this will involve also experts from the Ministry of Health. Orientation of M-Mama Champions; The community engagement through M-MAMA Champions is a devised intervention to empower other pregnant women by M-MAMA Champions after being oriented on the sensitization package. The orientation will be done by the researcher. After the orientation, the competence test will be taken by the M-MAMA Champions, and those who score an average score and above will be eligible to be involved in the study to deliver the intervention. The orientation package will entail the obstetric danger signs, birth preparedness, and complication readiness. Roles of M-Mama Champions The M-MAMA Champions after being empowered, will be carrying out the following duties. Creating awareness of the obstetric danger signs, and birth complication readiness and encourage for their practice. Each M-MAMA Champion, will be assigned and be responsible for empowering at least five ( 5 ) pregnant women, for a period of one month, she will hold a total of three sessions at an interval of two weeks. The sessions will be held at one of the pregnant women premise upon their agreement whereby all the pregnant women will come together, and have a sensitization session and the M-MAMA Champion will be a facilitator. Each sensitization session is devised not to exceed two ( 2 ) hours ( 24 ). Recruitment of Participants The recruitment of participants from the target population (pregnant women) from the study area will be as per the inclusion and exclusion criteria. The list of pregnant women from the selected clusters (villages or streets) will be developed from both the community health worker of the respective village or street and health records from the nearby health facility. 15 pregnant women will be studied per cluster, be it an intervention or control arm. Therefore, a pre-determined number of pregnant women per cluster will be obtained through random selection through a random number generator from the pregnant women list within the cluster. Physical visits to the pregnant women will be done and request them to participate in the study, obtaining the informed consent and followed by the baseline data collection. The study population for this study will include pregnant women who will be available in the study area during the study period. Inclusion criteria ; pregnant women in the first and second trimester (up to 28 weeks of GA). Exclusion Criteria ; include pregnant women; who will be sick and admitted, mentally incompetent, and those who won’t consent to participate in the study. Randomization The randomization will be done through simple randomization at the ward level. Each ward will consist of two villages/streets (clusters) with a pre-determined number of 15 pregnant women each as per inclusion criteria. Four ( 4 ) wards will be randomized to either the intervention or control arm at a ratio of 1:1 through a computerized random number generator that will be done using excel. Allocation sequence will be generated by the statistician by stipulating clear assumptions for each arm allocation from computer, followed by the cluster’s assignment to specific arms. This will ensure an equal opportunity for all the study participants within clusters to be randomized to either the intervention or the control groups, reduce contamination, and ensure baseline covariates balance between study arms. Intervention Arm; Those study participants randomized to the intervention arm will receive the intervention being tested in this study. The intervention will be community engagement that means creating awareness using the M-MAMA Champions on ODS, BP & CR to pregnant women. The sensitization package will be in a form of a brochure encompassing of obstetric danger signs, birth preparedness, and complication readiness, will be adapted from the Ministry of Health, Tanzania. The package source is being used to empower Community Health Workers (CHWs). The sensitization is designed to take place at one of the pregnant women residential areas, whereby the assigned group of pregnant women ranging from four ( 4 ) to eight ( 8 ) with one M-MAMA Champion as a facilitator will gather up for a period of not more than two ( 2 ) hours per session to a total of three ( 3 ) sessions to discuss about the package and their practice implication. The intervention is expected to be delivered in four ( 4 ) Clusters for a period of one month from March to April 2024 and raise awareness by at least 20% in the intervention arm within a study period. Control Arm; The study participants who will be randomized to the control arm won’t receive the intervention, instead, they will continue receiving the routine services. The routine services for pregnant women specifically on knowledge-related empowerment include the package delivered by the healthcare workers at the reproductive and child health clinics. The package is delivered during every ANC visit to the pregnant woman. The package contains basic information that is also tailored to the specific needs of pregnant women and is delivered with much emphasis to those who are prone to experience pregnancy-related complications for instance, those with Bad Obstetric History (BOH), cardiovascular diseases, or diabetics. Intervention Implementation Fidelity ; Several strategies have been put in place to ensure intervention implementation fidelity in this study. The strategies include; the researcher, two research assistants, and one Community Health Worker (CHW) from each village/street will pay close observation to the implementation of the intervention. M-MAMA Champions oriented before the intervention, a standard and valid intervention package adapted from the Ministry of Health, Tanzania. Blinding will be done to the statistician who will assist with data analysis, research assistants who will help with baseline and end line data collection and the study subjects themselves. Primary outcome Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women. Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on the awareness of the obstetric danger signs. It's anticipated that there will be a positive change in scores after the four ( 4 ) weeks of intervention. Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women. Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on awareness of birth preparedness and complication readiness after the intervention. It's anticipated that the majority will be able to name at least three ( 3 ) of five ( 5 ) key elements of birth preparedness and complication readiness after the four ( 4 ) weeks of intervention. Secondary Outcome Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness. Change in the scores from a semi-structured interviewer-administered questionnaire on the reported practice of birth preparedness and complication readiness among pregnant women after the four ( 4 ) weeks of intervention. the intervention. Sample Size Estimation and Sampling Technique Sample Size Estimation; The study will assess the effect of the M-MAMA champions in providing health education on obstetric danger signs whereby, the difference in the average in knowledge among pregnant women will be compared before and after the intervention. The sample size estimation formula as recommended by ( 25 ) Therefore, the sample size is as highlighted below The total sample size per arm plus a 20% attrition rate is 60 The study assumes a significance level of 5% and a power of 80%. The study subjects will be randomly allocated at a ratio of 1:1, therefore 60 subjects for the intervention arm versus 60 subjects for the control arm will be studied. Under this study, each cluster will constitute 15 subjects. Therefore, the intervention arm will have four ( 4 ) clusters, as well as the control arm making a total of eight ( 8 ) clusters. Sampling Technique; Multistage sampling technique will be employed for the selection of the study subjects for both the intervention and the control group. The first stage will be done through a simple random sampling through the lottery method of four ( 4 ) out of twenty-two ( 22 ) wards in Bahi District Council. It will be followed by the simple random sampling of two villages/streets from each ward, making a total of eight ( 8 ) clusters. The study subjects from each cluster will be randomly selected from the developed list of those who meet the inclusion criteria so as to meet the pre-determined number (15 subjects) per cluster. Therefore, a total of 120 subjects will be selected for the study. Variables and Variables Measurement Variables Definition; Pregnant women demographic characteristics and community engagement through M-MAMA Champions are the independent variables. The dependent (outcome) variables includes awareness on obstetric danger signs, birth preparedness and complication readiness among Pregnant women which are the primary outcomes and practice of birth preparedness and complication readiness is the secondary outcome. The obstetric danger signs referred in this proposal are those which occur during pregnancy which includes; - Abdominal pain, severe fatigue, vaginal bleeding, fever, difficulty in breathing, persistent headache, blurring vision, swelling/oedema of hand, face or feet, foul smell vaginal discharge, unconsciousness, convulsion, reduced foetal movement and pallor. Birth preparedness and complication readiness encompasses of five ( 5 ) key components which includes; 1) Identification of the place to give birth, 2) Identification of a potential blood donor, 3) Identification and selection of a skilled birth attendant, 4) Identification and selection of means of transportation in case of an emergency and 5) Saving money for emergency transportation( 28 ). Variable Measurement; An independent variable, demographic characteristics will be measured by three items (age, parity and gravidity) on a numerical scale, four items (place of residence, occupation, marital status and religion) on a nominal scale and one item (educational level) on an ordinal scale. The dependent (outcome) variables; Awareness on obstetric danger signs will be measured by eight ( 8 ) items on a binary scale. One point will be awarded for the correct answer and zero for the wrong answer. A total score will be eight ( 8 ), a mean score will be computed whereby those who will score above the mean will be considered to be aware and have good knowledge whereas those who will score below the mean will be considered to be unaware and have poor knowledge( 29 ). Awareness on birth preparedness and complication readiness (BP & CR) will be measured by five ( 5 ) items on a binary scale. One point will be awarded for the correct answer and zero for the wrong answer. A total score will be five ( 5 ), those who will be able to mention/identify at least three ( 3 ) out of five ( 5 ) BP & CR components will be regarded as being aware and have adequate knowledge on BP & CR( 30 ). Birth preparedness and complication readiness practice will be measured by five ( 5 ) items on a binary scale. One point will be awarded for the accomplished practice and zero for non-accomplished practice. A total score will be five ( 5 ), whereby those who will have accomplished at least three ( 3 ) out of five ( 5 ) birth preparedness and complication readiness factors will be regarded as having good practice of birth preparedness and complication readiness( 30 ). Data Collection Method and Instrument Data Collection Method; Survey through a structed questionnaire will be utilized in this study for data collection before and after the intervention. Data will be collected by both the researcher and the research assistants. Research assistants will professionally be either diploma or degree holders in health sciences, who will be trained before data collection commences. Data Collection Instrument; Data collection will employ a semi structured questionnaire. A questionnaire will be adapted from the JHPIEGO birth preparedness and complication readiness monitoring and survey tool ( 31 ) whereby the section on knowledge of obstetric danger signs, birth preparedness and complication readiness are the ones which will be adapted. Modification of the tool will be done to incorporate key questions from other literature on the same topic to meet the objectives under this study. The data collection to the sampled population will be done at both baseline and end line as indicated in the schematic summary of the intervention in Fig. 1 . Data management and Analysis Plan; All data collected will be treated as confidential, stored in the researcher’s laptop in a specific folder protected by a strong password that will be accessed only by the researcher and for research purposes as per the university of Dodoma (UDOM) policies. After the study is completed and the findings are published, the questionnaire with individual data will be destroyed, and the electronic data set will be kept by the researchers according to the university of Dodoma (UDOM) policies. After all the data are collected, analysis will be done using statistical package for social sciences (SPSS) version 27. Descriptive analysis will be used to summarize the socio-demographic characteristics, wealth profile and the frequency distribution of the items response to awareness on obstetric danger signs (ODS), awareness on the birth preparedness and complication readiness (BP&CR) and their practice. The results will be summarized using mean, standard deviation and proportions. Inferential analysis, will first be done through regression analysis to determine the correlation between socio-demographic characteristics, wealth profile and the level of awareness on obstetric danger signs, birth preparedness and complication readiness and their practice. A two tailed t-test will be used to test the comparison between the intervention and the control groups and determine the significance level, the significance level will be set at p < 0.05. A repeated ANOVA analysis will be employed to determine the effect of an intervention on the awareness of ODS, BP & CR and their practice, that will also factor in the role of possible confounders for control. The effect estimate will be presented with the odds ratio (OR), adjusted odds ratio (AOR) and their confidence intervals (CIs). Patient and Public Involvement; The public will be involved in the process of project implementation, whereby the CHWs will be part of the project observation. Also, the M-MAMA Champions, from the intervention clusters will be involved implementing the intervention being tested. Declarations Ethics ; This proposal has been reviewed and approved by the Research Ethical Committee of the University of Dodoma. Permission will be sought from authorities to the cluster level and informed consent and assent for those aged less than 18 years will be obtained before data collection commences from each participant and the parent/guardian respectively. Detailed information on the study aims and procedures, benefits, and risks to participants by participating in the study, participants’ role, and their ineffectual right to continue or withdraw from the study will be provided. The study will ensure the protection of the participants’ values, dignity, and integrity in accordance with the Helsinki Declaration by the World Medical Association. Dissemination ; The study results are expected to be disseminated via various forums beyond the dissertation submission as a partial fulfilment for attaining a master’s degree, Master of Science in Public Health of the University of Dodoma. It will be submitted to a reputable journal for publication, and will also be stored in the University of Dodoma repository, shared via various scientific forums, conferences, and the government through the Ministry of Health. Availability of data and materials ; The data that support the findings of this study will be made available from the University of Dodoma. Data are however available from the authors upon reasonable request and with permission of the University of Dodoma. Author Contributions; Alex Sanga ( [email protected] ); Introduction of the research Idea, Conceptualization of the research idea, drafting the research proposal, developing data collection tools, and contextualizing the training package. James Tumaini Kengia ( [email protected] ) ; Proposed the research study design, and the implementation research conceptual framework, edited the proposal, and reviewed the contextualized training package. Stephen Kibusi ( [email protected] ); Crafting the research objective, study design and research implementation framework, review of data collection tools, edited the proposal, and reviewed the contextualized training package. Funding statement ; This research was partially supported by the Ministry of Health, Tanzania (Ufadhili wa Masomo 2022/2023). Conflict of interest ; The researcher has no conflict of interest in this research. Acknowledgements; The research authors would like to thank the Ministry of Health Tanzania for their partial financial support to this study and PATHFINDER for sharing crucial information on the M-MAMA referral and emergency system in Tanzania. Author Correspondence ; Name; Alex Sanga, Post address Box 259 Dodoma, Email; [email protected] , Telephone Number +255 762 144 082, Trial registration; NCT06325319 (Effect of Community Engagement Using M-Mama Champions) References SDG. Transforming our world: the 2030 agenda for sustainable development. 2015. Elmusharaf K, Byrne E, Donovan DO. Strategies to increase demand for maternal health services in resource-limited settings : challenges to be addressed. BMC Public Health. 2015;1–10. Gesese SS, Mersha EA, Balcha WF. Knowledge of danger signs of pregnancy and health-seeking action among pregnant women : a health facility-based cross-sectional study. Ann Med Surg. 2023; Ramazani BI, Ntala SM, Ishoso DK, Rothan-tondeur M. Knowledge of Obstetric Danger Signs among Pregnant Women in the Eastern Democratic Republic of the Congo. Int J Environ Res Public Health. 2023;20(5593):1–15. Brian Barasa M, Mmusi-phetoe R. A Strategy for Reducing Maternal Mortality in Rural Kenya. 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Research Article Utilization of Maternal Postnatal Care Services Among Women in Selected Villages of Bahi District , Tanzania Utilization of Maternal Postnatal Care Services Among Women in Selected Villages of Bahi. Curr Res J Soc Sci. 2015;7(4):106–11. GA H, JM B, CS M, A RG, JC T, Mtose X. Development of a Co-Facilitator Training Programme to Conduct a Randomized Controlled Trial for a Health Promotion Programme at a Sub- Health Education Research & Development Development of a Co-Facilitator Training Programme to Conduct a Randomized Contr. Heal Educ Res Dev. 2016;4(2). Ayre J, Zhang M, Mouwad D, Zachariah D, Mccaffery KJ, Muscat DM. Systematic review of health literacy champions : who , what and how ? Heal Promot Int. 2023;38:1–16. Rutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized trials. Int J Epidemiol. 2015;1051–67. Campbell MK, Thomson S, Ramsay CR, Maclennan GS, Grimshaw JM. Sample size calculator for cluster randomized trials. Comput Biol Med. 2004;34:113–25. Killip S, Mahfoud Z, Pearce K. What Is an Intracluster Correlation Coeffi cient ? Crucial Concepts for DEFINITION AND EXPLANATION. Ann Fam Med ! 2004;204–8. Wudu MA, Tsegaye TB. Birth Preparedness and Complication Readiness and Associated Factors Among Recently Delivered Birth Preparedness and Complication Readiness and Associated Factors Among Recently Delivered Mothers in Mizan-Aman Town , Southwest Ethiopia , 2019. Int J Womens Health. 2022;13. Mesele TT, Syuom AT, Molla EA. Knowledge of danger signs in pregnancy and their associated factors among pregnant women in Hosanna Town, Hadiya Zone, southern Ethiopia. Front Reprod Heal. 2023;1–8. Letose F, Admassu B, Tura G. Birth preparedness , complication readiness and associated factors among pregnant women in Agnuak zone , Southwest Ethiopia : a community based comparative cross-sectional study. BMC Pregnancy Childbirth. 2020;20(72):1–15. JHPIEGO. Monitoring birth preparedness and complication readiness tools. 2004. Additional Declarations No competing interests reported. Supplementary Files SPIRITFillablechecklistStudyprotocol.doc Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version 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 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-4147830","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":286027737,"identity":"7ffc1e54-3bfc-4c0f-8979-c4f2a2f3a360","order_by":0,"name":"Alex Sanga","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA5ElEQVRIiWNgGAWjYBADGQYG5gNAWkKGaC08DAxsCSAtPKRo4TGAMggA+fazh1/8YLDj4ZfI+fzqRo0FDwP74aMb8GkxOJOXZtnDkMwj2XN2m3XOMaDDeNLSbuDVwpBjZsDDwMxjcLx3m3EOG1CLBI8ZXi3y/W/MDP8w1PPYH+Z5ZpzzjwgtDDdyjB/zMBzmMWDvYX6c20aEFoMbb8yYZQyO80icOWbGnNsnwcNGyC/y/TnGH99UVMvxz0h+/DnnW50cP/vhY/gdBoxCCQYDGANEElAOAswf0BmjYBSMglEwClAAAKvXP+a4g8J5AAAAAElFTkSuQmCC","orcid":"","institution":"The University of Dodoma","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Alex","middleName":"","lastName":"Sanga","suffix":""},{"id":286027738,"identity":"9686c93c-4c2a-4518-81a4-8527a7605ed8","order_by":1,"name":"Stephen Kibusi","email":"","orcid":"","institution":"The University of Dodoma","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Stephen","middleName":"","lastName":"Kibusi","suffix":""},{"id":286027739,"identity":"f55e6995-4ade-4b4a-9766-1551b7b7aa6f","order_by":2,"name":"James Tumaini Kengia","email":"","orcid":"","institution":"The University of Dodoma","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"James","middleName":"Tumaini","lastName":"Kengia","suffix":""}],"badges":[],"createdAt":"2024-03-22 07:27:03","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4147830/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4147830/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":53961401,"identity":"943613e7-80aa-45d3-9d0e-43a5ae6abc27","added_by":"auto","created_at":"2024-04-02 18:04:39","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":44218,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe schematic diagram of the timelines of events for implementing the study\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-4147830/v1/b7abff3a555e2f702e14b8de.png"},{"id":67883485,"identity":"e0729405-2b73-408d-a12c-2deaec328df8","added_by":"auto","created_at":"2024-10-30 17:31:44","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":745131,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4147830/v1/06688333-9528-47eb-b4d7-6028c882a6aa.pdf"},{"id":53961402,"identity":"4c265de0-d9aa-46cd-b75a-75490894cb30","added_by":"auto","created_at":"2024-04-02 18:04:39","extension":"doc","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":125440,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITFillablechecklistStudyprotocol.doc","url":"https://assets-eu.researchsquare.com/files/rs-4147830/v1/1c0aacd894081f839116d69c.doc"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effectiveness of Community Engagement Using M-Mama Champions in Improving Literacy of Obstetric Danger Signs, Birth Preparedness and Complication Readiness Among Pregnant Women in Bahi, Dodoma. A Community-Based, Cluster Randomized Controlled Trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eMaternal mortality remains a global public health issue, despite the global initiative to reduce it to meet the targets under Sustainable Development Goal 3, which envisages reducing it to less than 70 for every 100,000 live births by 2030 globally(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Maternal mortality commonly occurs during intrapartum and the first day post-partum(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) and Obstetric danger signs account for more than 75% of all obstetric complications leading to maternal deaths(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). However, there is still low knowledge of obstetric danger signs, birth preparedness, and complication readiness and their practice among pregnant women, which plays a significant role in the slow pace of maternal mortality reduction(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe global average of maternal mortality ratio is 256 per 100,000 live births, which is equivalent to 810 maternal deaths occurring due to pregnancy and childbirth-related complications daily(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Tanzania\u0026rsquo;s maternal mortality ratio is estimated to be 104 per 100,000 live births(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e), which is still higher than the SDG target to be attained by 2030(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Therefore, innovations that are community-based like M-MAMA referral and emergency systems are necessary to address the second delay as an attribute of maternal mortality, in Tanzania(\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe majority of maternal deaths occur in Sub-Saharan Africa, which accounted for two-thirds of global maternal deaths in 2017(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Through a three-delay model, three factors contribute to maternal mortality, delay in deciding to seek care, access a health facility, and receive optimal care once one has arrived at a health facility for definitive care(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eMaternal mortality as a good indicator of the utilization of health services(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) is undeniably a terrible injustice for it leads to several detrimental impacts on families and family members' physical and mental health. It is therefore crucial that the maternal mortality rate is reduced to the lowest possible figures to avoid those negative effects(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe low knowledge of obstetric danger signs among couples especially those with low literacy (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) is among the factors that leads to the first delay which ultimately leads to maternal mortality. It\u0026rsquo;s essential to help the couples prepare in advance for childbirth and make prompt decisions in case of obstetric emergencies for such interventions targeting the first delay, work in tandem with interventions targeting the second and third delays(\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). This is justified by the high coverage of essential interventions in healthcare facilities haven\u0026rsquo;t been able to reduce maternal mortality due to poor service utilization. Lack of knowledge of the importance of seeking medical attention during pregnancy and labour among pregnant women negatively influences health behaviour and decision-making processes(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Empowering women with knowledge of Obstetric Danger Sings (ODS) ensures that they are capable of taking ownership of the decisions about their care at the right time without relying on others to make decisions for them.\u003c/p\u003e \u003cp\u003eCommunity-based interventions have shown to contribute significantly in reducing maternal mortality, especially in rural settings (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). This includes the training of community health extension workers to recognize obstetric danger signs in pregnancy and make prompt decisions to seek care. Women groups have also been determined to be very effective (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Women groups are utilized for learning through participatory learning and action (PLA) (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e), comprising four phases: identification and prioritization of maternal problems, planning for locally feasible solutions, implementation and assessment, through stories, games, and pictures to discuss prevention, care seeking and treatment for common maternal problems(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) with 88% reduction of maternal deaths (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). M-MAMA Champions, are designed to provide health education in the form of women groups coupled with their experience from M-MAMA referral and emergency services to potentiate the positive gains from the program in all the regions in Tanzania. This will ensure that knowledge on obstetric danger signs among pregnant women is enhanced and contribute towards birth preparedness and complication readiness that ultimately contributes to maternal mortality reduction (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e\n\u003ch3\u003eM-MAMA Referral and Emergency System\u003c/h3\u003e\n\u003cp\u003eM-MAMA referral and emergency system is a local initiative developed in Tanzania by development partners (Touch Foundation, PATHFINDER) in collaboration with the health sector (Ministry of Health and President\u0026rsquo;s Office regional administration and local government), funded by Vodafone Foundation and the Government of Tanzania, aiming at improving maternal health through mobile services (Mobile maternal health \u0026ndash; M-MAMA) in the country. The pilot results from Shinyanga, Buchosa, and Sengerema councils, from 2013 to 2017, lead to the scale up of the program from 2022 in all the regions in Tanzania mainland and Zanzibar Island.\u003c/p\u003e \u003cp\u003eThe M-MAMA program inception targets maternal mortality reduction through devised strategies according to the three-delay framework. The devised interventions for each delay phase include community awareness creation through Community health workers (CHWs) to empower the community with knowledge on obstetric emergencies, advocate for the newly introduced services, promote the use of a toll-free number (115), and create service utilization demand. Utilization of the available ambulances for emergency transportation, and in case an Ambulance is not available, the identified, trained, and contracted community taxi drivers for the emergency transportation to avoid the second delay from both community-to-facility and interfacility transport. The program operational costs are carried out by the Government of the United Republic of Tanzania for sustainability. In the pilot, the program has been determined to be cost-effective in shortening the second delay compared to routine ambulance use (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e), whereby maternal mortality declined by 70% within two years.\u003c/p\u003e \u003cp\u003eAlso, the program trained healthcare workers on proper management of obstetric emergencies, renovated healthcare facilities, specifically the operating theaters, and supplied equipment and supplies to the referral facilities which provided comprehensive or basic emergency obstetric and neonatal care (CEmONC or BEmONC) to avoid third delay. The program established Dispatch centers, stationed at either the regional referral hospital or the selected council hospitals, each equipped with a human resource (locally available), remote triage tablet, and a mobile phone with a toll-free number for communication. The emergency response process is envisaged to be initiated by either the community or the lower-level healthcare facility through a call. However, during the scale-up of the program to the rest of the regions, some interventions were dropped including the community awareness creation that was left to be addressed by other programs through government efforts or other funding opportunities by other development or implementing partners.\u003c/p\u003e\n\u003ch3\u003eAim of the study\u003c/h3\u003e\n\u003cp\u003eThis study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness and Complication Readiness among Pregnant Women in Bahi, Dodoma. The specific objectives are.\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs among pregnant women.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo determine the effectiveness of community engagement using M-MAMA Champions on awareness of birth preparedness and complication readiness among pregnant women.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo determine the effectiveness of community engagement using M-MAMA Champions on the practice of birth preparedness and complication readiness among pregnant women.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eResearch Hypothesis\u003c/h2\u003e \u003cp\u003e \u003cb\u003eNull Hypothesis\u003c/b\u003e; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches like CHWs/HCWs.\u003c/p\u003e \u003cp\u003e \u003cb\u003eAlternative hypothesis;\u003c/b\u003e Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness and Complication Readiness among Pregnant Women is more effective than routine approaches like CHWs/HCWs.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eOperational definitions\u003c/h2\u003e \u003cp\u003e \u003cb\u003eM-MAMA referral and emergency system\u003c/b\u003e refer to the systems that transport pregnant women from either community or lower to the higher-level facilities for definitive care, to reduce second delay, attributed to maternal death.\u003c/p\u003e \u003cp\u003e \u003cb\u003eM-MAMA Champions\u003c/b\u003e refers to the mothers who have received the M-MAMA referral and emergency services during their previous delivery, are ready and willing to empower other pregnant women, residing in the communities where the study will be conducted.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eCommunity engagement using M-MAMA Champions\u003c/strong\u003e \u003cp\u003erefers to the utilization of women who are the beneficiaries of the M-MAMA program to mobilize pregnant women in their localities to create awareness and improve their knowledge on obstetric danger signs, birth preparedness and complication readiness in the form of women groups, whereby the M-MAMA Champions act as facilitators within the groups.\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Methods","content":"\u003cp\u003e \u003cb\u003eStudy Setting;\u003c/b\u003e The study will be conducted in Bahi, Dodoma. Dodoma is Tanzania’s capital city located in the central zone and borders Morogoro to the east, Iringa to the south, Singida to the west, and Manyara to the North. Dodoma region has 3,085,625 people, of which nearly 10% (322,526) constitute the population residing in the Bahi council (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Dodoma region is one of the regions with the highest maternal mortality rate in the country estimated to be 417 per 100,000 live births (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e), while Bahi District Council maternal mortality ratio (MMR) is estimated to be 400 deaths per 100,000 births, that makes it the second council with the high MMR among the councils of Dodoma region (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cb\u003eStudy Design;\u003c/b\u003e A parallel group, Cluster randomized controlled trial (cRCT) study design will be used for this study, whereby the Obstetric danger signs (ODS), birth preparedness, and complication readiness (BP \u0026amp; CR) sensitization intervention will be provided in clusters that will randomly be assigned to the intervention arm. The clusters are designed at the village or street level. The sensitization will be provided by the M-MAMA Champions after being empowered on the adapted training package. The M-MAMA Champions will be identified within the intervention clusters through the M-MAMA database and health facility registries of post-natal mothers who will have benefited from the program about their address to determine their location as per the cluster allocated. M-MAMA Champions as a group being tested for sensitization on obstetric danger signs, birth preparedness, and complication readiness in their respective communities have been targeted as a potential group to have benefited from the M-MAMA services thence will be resourceful to empower other pregnant women on ODS, BP \u0026amp; CR and narrate their experiences and benefits they obtained from the program when those danger signs were noted to enhance understanding and practice of birth preparedness and complication readiness. The engagement will be done through participatory learning and action, whereby the M-MAMA Champions will play a role of facilitators. The clusters that will randomly be assigned to the control group won’t receive any intervention. Schematic diagrammatic schedule indicating the steps to be followed during the implementation of the research is as stipulated in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e "},{"header":"Recruitment and Training of M-Mama Champions","content":"\u003cp\u003e\u003cstrong\u003eRecruitment;\u003c/strong\u003e The M-MAMA Champions will be identified and recruited from clusters that will be randomized to the intervention arm. The exact source of M-MAMA Champions will be the M-MAMA database which is housed at the President’s Office of Regional Administration and Local Government and the health facilities in the respective clusters. The database contains the client’s details of the referring and receiving health facilities to which the client attended and the date of the referral. It is presumed, that the contact details will be obtained at the referring health facility through health facility records.\u003c/p\u003e\n\u003cp\u003eThe \u003cstrong\u003einclusion criteria of M-MAMA Champions\u003c/strong\u003e, those aged 15 to 49 years, at least 3 months post-delivery, primary education, ready, and volunteering to empower other women (\u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eThe selected M-MAMA Champions will be contacted via phone call and requested to participate in the study, followed by physical contact, whereby the consent form will be presented for them to sign. It will then be followed by the collective orientation of the package to be used for empowering pregnant women with knowledge of obstetric danger signs, birth preparedness, and complication readiness (\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e). A simple random selection of three (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) M-MAMA Champions per cluster will be done, among those who will have attained a minimum competence score after the orientation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTraining Package Customization;\u003c/strong\u003e The Tanzania Ministry of Health package or module on basics of reproductive, maternal, new-born, child, and adolescent health for community health workers, which contains 18 sessions will be adapted and customized based on the study requirements (ODS, BP \u0026amp;CR) to suit the intended intervention to the target population. The package will be customized through an extraction of the specific sessions; whereby other unintended contents won’t be included. It will be followed by the review of the newly customized package by the experts for comments, which will be worked up accordingly. The proposed package will be translated into Kiswahili, which will also be reviewed by the experts for comments on the understanding, language of the target group, and the friendliness to the readers, this will involve also experts from the Ministry of Health.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOrientation of M-Mama Champions;\u003c/strong\u003e The community engagement through M-MAMA Champions is a devised intervention to empower other pregnant women by M-MAMA Champions after being oriented on the sensitization package. The orientation will be done by the researcher. After the orientation, the competence test will be taken by the M-MAMA Champions, and those who score an average score and above will be eligible to be involved in the study to deliver the intervention. The orientation package will entail the obstetric danger signs, birth preparedness, and complication readiness.\u003c/p\u003e\n\u003ch2\u003eRoles of M-Mama Champions\u003c/h2\u003e\n\u003cp\u003eThe M-MAMA Champions after being empowered, will be carrying out the following duties. Creating awareness of the obstetric danger signs, and birth complication readiness and encourage for their practice. Each M-MAMA Champion, will be assigned and be responsible for empowering at least five (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e) pregnant women, for a period of one month, she will hold a total of three sessions at an interval of two weeks. The sessions will be held at one of the pregnant women premise upon their agreement whereby all the pregnant women will come together, and have a sensitization session and the M-MAMA Champion will be a facilitator. Each sensitization session is devised not to exceed two (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e) hours (\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e).\u003c/p\u003e\n\u003ch2\u003eRecruitment of Participants\u003c/h2\u003e\n\u003cp\u003eThe recruitment of participants from the target population (pregnant women) from the study area will be as per the inclusion and exclusion criteria. The list of pregnant women from the selected clusters (villages or streets) will be developed from both the community health worker of the respective village or street and health records from the nearby health facility. 15 pregnant women will be studied per cluster, be it an intervention or control arm. Therefore, a pre-determined number of pregnant women per cluster will be obtained through random selection through a random number generator from the pregnant women list within the cluster. Physical visits to the pregnant women will be done and request them to participate in the study, obtaining the informed consent and followed by the baseline data collection.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe study population\u003c/strong\u003e for this study will include pregnant women who will be available in the study area during the study period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion criteria\u003c/strong\u003e; pregnant women in the first and second trimester (up to 28 weeks of GA).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion Criteria\u003c/strong\u003e; include pregnant women; who will be sick and admitted, mentally incompetent, and those who won’t consent to participate in the study.\u003c/p\u003e\n\u003ch2\u003eRandomization\u003c/h2\u003e\n\u003cp\u003eThe randomization will be done through simple randomization at the ward level. Each ward will consist of two villages/streets (clusters) with a pre-determined number of 15 pregnant women each as per inclusion criteria. Four (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) wards will be randomized to either the intervention or control arm at a ratio of 1:1 through a computerized random number generator that will be done using excel. Allocation sequence will be generated by the statistician by stipulating clear assumptions for each arm allocation from computer, followed by the cluster’s assignment to specific arms. This will ensure an equal opportunity for all the study participants within clusters to be randomized to either the intervention or the control groups, reduce contamination, and ensure baseline covariates balance between study arms.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention Arm;\u003c/strong\u003e Those study participants randomized to the intervention arm will receive the intervention being tested in this study. The intervention will be community engagement that means creating awareness using the M-MAMA Champions on ODS, BP \u0026amp; CR to pregnant women. The sensitization package will be in a form of a brochure encompassing of obstetric danger signs, birth preparedness, and complication readiness, will be adapted from the Ministry of Health, Tanzania. The package source is being used to empower Community Health Workers (CHWs). The sensitization is designed to take place at one of the pregnant women residential areas, whereby the assigned group of pregnant women ranging from four (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) to eight (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e) with one M-MAMA Champion as a facilitator will gather up for a period of not more than two (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e) hours per session to a total of three (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) sessions to discuss about the package and their practice implication. The intervention is expected to be delivered in four (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) Clusters for a period of one month from March to April 2024 and raise awareness by at least 20% in the intervention arm within a study period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eControl Arm;\u003c/strong\u003e The study participants who will be randomized to the control arm won’t receive the intervention, instead, they will continue receiving the routine services. The routine services for pregnant women specifically on knowledge-related empowerment include the package delivered by the healthcare workers at the reproductive and child health clinics. The package is delivered during every ANC visit to the pregnant woman. The package contains basic information that is also tailored to the specific needs of pregnant women and is delivered with much emphasis to those who are prone to experience pregnancy-related complications for instance, those with Bad Obstetric History (BOH), cardiovascular diseases, or diabetics.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention Implementation Fidelity\u003c/strong\u003e; Several strategies have been put in place to ensure intervention implementation fidelity in this study. The strategies include; the researcher, two research assistants, and one Community Health Worker (CHW) from each village/street will pay close observation to the implementation of the intervention. M-MAMA Champions oriented before the intervention, a standard and valid intervention package adapted from the Ministry of Health, Tanzania. Blinding will be done to the statistician who will assist with data analysis, research assistants who will help with baseline and end line data collection and the study subjects themselves.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePrimary outcome\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cspan\u003eImprovement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women. Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on the awareness of the obstetric danger signs. It's anticipated that there will be a positive change in scores after the four (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) weeks of intervention.\u003cbr\u003e\u003c/span\u003e\u003cspan\u003eImprovement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women. Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on awareness of birth preparedness and complication readiness after the intervention. It's anticipated that the majority will be able to name at least three (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) of five (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e) key elements of birth preparedness and complication readiness after the four (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) weeks of intervention.\u003cbr\u003e\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSecondary Outcome\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cspan\u003eImprovement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness. Change in the scores from a semi-structured interviewer-administered questionnaire on the reported practice of birth preparedness and complication readiness among pregnant women after the four (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) weeks of intervention. the intervention.\u003cbr\u003e\u003c/span\u003e\u003c/p\u003e\n\u003ch2\u003eSample Size Estimation and Sampling Technique\u003c/h2\u003e\n\u003cp\u003eSample Size Estimation; The study will assess the effect of the M-MAMA champions in providing health education on obstetric danger signs whereby, the difference in the average in knowledge among pregnant women will be compared before and after the intervention. The sample size estimation formula as recommended by (\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e) Therefore, the sample size is as highlighted below\u003c/p\u003e\n\u003cp\u003e\u003cimg src=\"https://myfiles.space/user_files/122228_c8a1650c59388082/122228_custom_files/img1712051884.png\"\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cimg src=\"https://myfiles.space/user_files/122228_c8a1650c59388082/122228_custom_files/img1712051907.png\"\u003e\u003cbr\u003e\u003c/p\u003e\n\u003ch2\u003eThe total sample size per arm plus a 20% attrition rate is 60\u003c/h2\u003e\n\u003cp\u003eThe study assumes a significance level of 5% and a power of 80%. The study subjects will be randomly allocated at a ratio of 1:1, therefore 60 subjects for the intervention arm versus 60 subjects for the control arm will be studied. Under this study, each cluster will constitute 15 subjects. Therefore, the intervention arm will have four (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) clusters, as well as the control arm making a total of eight (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e) clusters.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSampling Technique;\u003c/strong\u003e Multistage sampling technique will be employed for the selection of the study subjects for both the intervention and the control group. The first stage will be done through a simple random sampling through the lottery method of four (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) out of twenty-two (\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e) wards in Bahi District Council. It will be followed by the simple random sampling of two villages/streets from each ward, making a total of eight (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e) clusters. The study subjects from each cluster will be randomly selected from the developed list of those who meet the inclusion criteria so as to meet the pre-determined number (15 subjects) per cluster. Therefore, a total of 120 subjects will be selected for the study.\u003c/p\u003e\n\u003ch2\u003eVariables and Variables Measurement\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eVariables Definition;\u003c/strong\u003e Pregnant women demographic characteristics and community engagement through M-MAMA Champions are the independent variables. The dependent (outcome) variables includes awareness on obstetric danger signs, birth preparedness and complication readiness among Pregnant women which are the primary outcomes and practice of birth preparedness and complication readiness is the secondary outcome.\u003c/p\u003e\n\u003cp\u003eThe obstetric danger signs referred in this proposal are those which occur during pregnancy which includes; - Abdominal pain, severe fatigue, vaginal bleeding, fever, difficulty in breathing, persistent headache, blurring vision, swelling/oedema of hand, face or feet, foul smell vaginal discharge, unconsciousness, convulsion, reduced foetal movement and pallor.\u003c/p\u003e\n\u003cp\u003eBirth preparedness and complication readiness encompasses of five (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e) key components which includes; 1) Identification of the place to give birth, 2) Identification of a potential blood donor, 3) Identification and selection of a skilled birth attendant, 4) Identification and selection of means of transportation in case of an emergency and 5) Saving money for emergency transportation(\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eVariable Measurement;\u003c/strong\u003e An independent variable, demographic characteristics will be measured by three items (age, parity and gravidity) on a numerical scale, four items (place of residence, occupation, marital status and religion) on a nominal scale and one item (educational level) on an ordinal scale.\u003c/p\u003e\n\u003cp\u003eThe dependent (outcome) variables; Awareness on obstetric danger signs will be measured by eight (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e) items on a binary scale. One point will be awarded for the correct answer and zero for the wrong answer. A total score will be eight (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e), a mean score will be computed whereby those who will score above the mean will be considered to be aware and have good knowledge whereas those who will score below the mean will be considered to be unaware and have poor knowledge(\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eAwareness on birth preparedness and complication readiness (BP \u0026amp; CR) will be measured by five (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e) items on a binary scale. One point will be awarded for the correct answer and zero for the wrong answer. A total score will be five (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e), those who will be able to mention/identify at least three (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) out of five (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e) BP \u0026amp; CR components will be regarded as being aware and have adequate knowledge on BP \u0026amp; CR(\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eBirth preparedness and complication readiness practice will be measured by five (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e) items on a binary scale. One point will be awarded for the accomplished practice and zero for non-accomplished practice. A total score will be five (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e), whereby those who will have accomplished at least three (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) out of five (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e) birth preparedness and complication readiness factors will be regarded as having good practice of birth preparedness and complication readiness(\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e).\u003c/p\u003e\n\n\n\n\n"},{"header":"Data Collection Method and Instrument","content":"\u003cp\u003e\u003cstrong\u003eData Collection Method;\u003c/strong\u003e Survey through a structed questionnaire will be utilized in this study for data collection before and after the intervention. Data will be collected by both the researcher and the research assistants. Research assistants will professionally be either diploma or degree holders in health sciences, who will be trained before data collection commences.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eData Collection Instrument;\u003c/strong\u003e Data collection will employ a semi structured questionnaire. A questionnaire will be adapted from the JHPIEGO birth preparedness and complication readiness monitoring and survey tool (\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e) whereby the section on knowledge of obstetric danger signs, birth preparedness and complication readiness are the ones which will be adapted. Modification of the tool will be done to incorporate key questions from other literature on the same topic to meet the objectives under this study. The data collection to the sampled population will be done at both baseline and end line as indicated in the schematic summary of the intervention in Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eData management and Analysis Plan;\u003c/strong\u003e All data collected will be treated as confidential, stored in the researcher’s laptop in a specific folder protected by a strong password that will be accessed only by the researcher and for research purposes as per the university of Dodoma (UDOM) policies. After the study is completed and the findings are published, the questionnaire with individual data will be destroyed, and the electronic data set will be kept by the researchers according to the university of Dodoma (UDOM) policies. After all the data are collected, analysis will be done using statistical package for social sciences (SPSS) version 27. Descriptive analysis will be used to summarize the socio-demographic characteristics, wealth profile and the frequency distribution of the items response to awareness on obstetric danger signs (ODS), awareness on the birth preparedness and complication readiness (BP\u0026amp;CR) and their practice. The results will be summarized using mean, standard deviation and proportions. Inferential analysis, will first be done through regression analysis to determine the correlation between socio-demographic characteristics, wealth profile and the level of awareness on obstetric danger signs, birth preparedness and complication readiness and their practice. A two tailed t-test will be used to test the comparison between the intervention and the control groups and determine the significance level, the significance level will be set at p \u0026lt; 0.05. A repeated ANOVA analysis will be employed to determine the effect of an intervention on the awareness of ODS, BP \u0026amp; CR and their practice, that will also factor in the role of possible confounders for control. The effect estimate will be presented with the odds ratio (OR), adjusted odds ratio (AOR) and their confidence intervals (CIs).\u003c/p\u003e\u003cp\u003e\u003cstrong\u003ePatient and Public Involvement;\u003c/strong\u003e The public will be involved in the process of project implementation, whereby the CHWs will be part of the project observation. Also, the M-MAMA Champions, from the intervention clusters will be involved implementing the intervention being tested.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics\u003c/strong\u003e; This proposal has been reviewed and approved by the Research Ethical Committee of the University of Dodoma. Permission will be sought from authorities to the cluster level and informed consent and assent for those aged less than 18 years will be obtained before data collection commences from each participant and the parent/guardian respectively. Detailed information on the study aims and procedures, benefits, and risks to participants by participating in the study, participants\u0026rsquo; role, and their ineffectual right to continue or withdraw from the study will be provided. The study will ensure the protection of the participants\u0026rsquo; values, dignity, and integrity in accordance with the Helsinki Declaration by the World Medical Association. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination\u003c/strong\u003e; The study results are expected to be disseminated via various forums beyond the dissertation submission as a partial fulfilment for attaining a master\u0026rsquo;s degree, Master of Science in Public Health of the University of Dodoma. It will be submitted to a reputable journal for publication, and will also be stored in the University of Dodoma repository, shared via various scientific forums, conferences, and the government through the Ministry of Health. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e; The data that support the findings of this study will be made available from the University of Dodoma. Data are however available from the authors upon reasonable request and with permission of the University of Dodoma. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions;\u003c/strong\u003e\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\u003cstrong\u003eAlex Sanga \u003c/strong\u003e([email protected]); Introduction of the research Idea, Conceptualization of the research idea, drafting the research proposal, developing data collection tools, and contextualizing the training package. \u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eJames Tumaini Kengia \u003c/strong\u003e([email protected])\u003cstrong\u003e;\u003c/strong\u003e Proposed the research study design, and the implementation research conceptual framework, edited the proposal, and reviewed the contextualized training package. \u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eStephen Kibusi \u003c/strong\u003e([email protected]); Crafting the research objective, study design and research implementation framework, review of data collection tools, edited the proposal, and reviewed the contextualized training package. \u003c/li\u003e\n\u003c/ol\u003e\n\n\u003cp\u003e\u003cstrong\u003eFunding statement\u003c/strong\u003e; This research was partially supported by the Ministry of Health, Tanzania (Ufadhili wa Masomo 2022/2023).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of\u003c/strong\u003e\u003cstrong\u003e interest\u003c/strong\u003e\u003cstrong\u003e; \u003c/strong\u003eThe researcher has no conflict of interest in this research.\u003cstrong\u003e \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements; \u003c/strong\u003eThe research authors would like to thank the Ministry of Health Tanzania for their partial financial support to this study and PATHFINDER for sharing crucial information on the M-MAMA referral and emergency system in Tanzania.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eAuthor Correspondence\u003c/strong\u003e; Name; Alex Sanga, Post address Box 259 Dodoma, Email; [email protected], Telephone Number +255 762 144 082,\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration;\u0026nbsp;\u003c/strong\u003eNCT06325319 (Effect of Community Engagement Using M-Mama Champions)\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSDG. 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Emergency Transportation Interventions for Reducing Adverse Pregnancy Outcomes in Low- and Middle-Income Countries : A Systematic Review. 2020;(December). \u003c/li\u003e\n\u003cli\u003eUSAID. M-Mama_Revised Assessment Report_30012023. 2023. \u003c/li\u003e\n\u003cli\u003eVossius C, Mduma E, Moshiro R, Mdoe P, Kval\u0026oslash;y JT, Kidanto H, et al. The impact of introducing ambulance and delivery fees in a rural hospital in Tanzania. BMC Health Serv Res. 2021;21(1):1\u0026ndash;9. \u003c/li\u003e\n\u003cli\u003eOrjingene O, Morgan J. Effectiveness of Community Based Interventions in Reducing Maternal Mortality in Sub-Saharan Africa : A Systematic Review Effectiveness of Community Based Interventions in Reducing Maternal Mortality in Sub-Saharan Africa : A Systematic Review. Int J Trop Dis Heal. 2020;41(9). \u003c/li\u003e\n\u003cli\u003eWHO. Maternal Health. 2017. \u003c/li\u003e\n\u003cli\u003eJoiner A, Lee A, Chowa P, Kharel R, Kumar L, Caruzzo NM, et al. PLOS ONE Access to care solutions in healthcare for obstetric care in Africa : A systematic review. PLoS One [Internet]. 2021;1\u0026ndash;27. Available from: http://dx.doi.org/10.1371/journal.pone.0252583\u003c/li\u003e\n\u003cli\u003eNBS. Popoulation Size (1). 2022. \u003c/li\u003e\n\u003cli\u003eNassoro MM, Chetto P, Chiwanga E, Lilungulu A, Bintabara D, Wambura J. Maternal Mortality in Dodoma Regional Referral. Int J Reprod Med. 2020;2020. \u003c/li\u003e\n\u003cli\u003eLwelamira J, Safari J, Stephen A. Research Article Utilization of Maternal Postnatal Care Services Among Women in Selected Villages of Bahi District , Tanzania Utilization of Maternal Postnatal Care Services Among Women in Selected Villages of Bahi. Curr Res J Soc Sci. 2015;7(4):106\u0026ndash;11. \u003c/li\u003e\n\u003cli\u003eGA H, JM B, CS M, A RG, JC T, Mtose X. Development of a Co-Facilitator Training Programme to Conduct a Randomized Controlled Trial for a Health Promotion Programme at a Sub- Health Education Research \u0026amp; Development Development of a Co-Facilitator Training Programme to Conduct a Randomized Contr. Heal Educ Res Dev. 2016;4(2). \u003c/li\u003e\n\u003cli\u003eAyre J, Zhang M, Mouwad D, Zachariah D, Mccaffery KJ, Muscat DM. Systematic review of health literacy champions : who , what and how ? Heal Promot Int. 2023;38:1\u0026ndash;16. \u003c/li\u003e\n\u003cli\u003eRutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized trials. Int J Epidemiol. 2015;1051\u0026ndash;67. \u003c/li\u003e\n\u003cli\u003eCampbell MK, Thomson S, Ramsay CR, Maclennan GS, Grimshaw JM. Sample size calculator for cluster randomized trials. Comput Biol Med. 2004;34:113\u0026ndash;25. \u003c/li\u003e\n\u003cli\u003eKillip S, Mahfoud Z, Pearce K. What Is an Intracluster Correlation Coeffi cient ? Crucial Concepts for DEFINITION AND EXPLANATION. Ann Fam Med ! 2004;204\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eWudu MA, Tsegaye TB. Birth Preparedness and Complication Readiness and Associated Factors Among Recently Delivered Birth Preparedness and Complication Readiness and Associated Factors Among Recently Delivered Mothers in Mizan-Aman Town , Southwest Ethiopia , 2019. Int J Womens Health. 2022;13. \u003c/li\u003e\n\u003cli\u003eMesele TT, Syuom AT, Molla EA. Knowledge of danger signs in pregnancy and their associated factors among pregnant women in Hosanna Town, Hadiya Zone, southern Ethiopia. Front Reprod Heal. 2023;1\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eLetose F, Admassu B, Tura G. Birth preparedness , complication readiness and associated factors among pregnant women in Agnuak zone , Southwest Ethiopia : a community based comparative cross-sectional study. BMC Pregnancy Childbirth. 2020;20(72):1\u0026ndash;15. \u003c/li\u003e\n\u003cli\u003eJHPIEGO. Monitoring birth preparedness and complication readiness tools. 2004. \u003c/li\u003e\n\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Obstetric Danger Signs, Birth Preparedness and Complication Readiness, M-MAMA Champion, Participatory Learning and Action, Women Groups","lastPublishedDoi":"10.21203/rs.3.rs-4147830/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4147830/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003cem\u003e: \u003c/em\u003eMaternal mortality remains a global public health issue, Sustainable Development Goal 3 targets to reduce it to less than 70 for every 100,000 live births by 2030. Maternal mortality whose peak is during intrapartum and the first day post-partum, 75% of it is accounted for by obstetric danger signs complications. \u0026nbsp;Tanzania’s maternal mortality ratio stands at 104 for every 100,000 live births higher than the SDG target. Innovations that include M-MAMA Champions as facilitators in women groups are necessary to improve the literacy level of obstetric danger signs, birth preparedness, and complication readiness among pregnant women and enhance obstetric emergency response and service utilization, for essential interventions in healthcare facilities alone haven’t been able to reduce maternal mortality due to poor services utilization.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003cem\u003e\u003cstrong\u003e \u003c/strong\u003e\u003c/em\u003eIn a community-based, parallel-group cluster randomized controlled trial (cRCT) design, a total of 120 first and second-trimester pregnant women will be randomized at a ratio of 1:1 to the intervention and control groups. The sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm will be done for a period of one month, each two-hour session will be delivered in an interval of two weeks, using participatory learning and action model. The effect of the intervention will be determined using repeated ANOVA analysis, of which the effect of M-MAMA Champions on literacy level and practice between arms will be determined.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion;\u003c/strong\u003e Implementation fidelity of the intervention will be ensured through implementation observation by the researcher, research assistants, and the community health workers.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e; The University of Dodoma Research Ethics Committee approved this study (Ref. No. MA.84/261/02/1/115). The study will ensure the protection of the participants’ values, dignity, and integrity per the Helsinki Declaration by the World Medical Association.\u003c/p\u003e","manuscriptTitle":"Effectiveness of Community Engagement Using M-Mama Champions in Improving Literacy of Obstetric Danger Signs, Birth Preparedness and Complication Readiness Among Pregnant Women in Bahi, Dodoma. 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