A community-based cluster randomized controlled trial (cRCT) to evaluate the impact and operational assessment of "safe motherhood and newborn health promotion package": study protocol

Abstract

Background: Despite considerable progress in reduction of both under-five and maternal mortality in recent decades, Bangladesh is still one of the low and middle income countries with high burden of maternal and neonatal mortality. The primary objective of the current study is to measure the impact of a comprehensive package of interventions on maternal and neonatal mortality. In addition, changes in coverage, quality and utilization of maternal and newborn health (MNH) services, social capital, and cost effectiveness of the interventions will be measured.

Methods: A community-based, cluster randomized controlled trial design will be adopted and implemented in 30 unions of three sub-districts of Chandpur district of Bangladesh. Every union, the lowest administrative unit of the local government with population of around 20,000-30,000, will be considered a cluster. Based on the baseline estimates, 15 clusters will be paired for random assignment as intervention and comparison clusters. The primary outcome measure is neonatal mortality, and secondary outcomes are coverage of key interventions like ANC, PNC, facility and skilled provider delivery. Baseline, midterm and endline household survey will be conducted to assess the key coverage of interventions. Health facility assessment surveys will be conducted periodically to assess facility readiness and utilization of MNH services in the participating health facilities.

Discussion: The current study is expected to provide essential strong evidences on the impact of a comprehensive package of interventions to the Bangladesh government, and other developmental partners. The study results may help in prioritizing, planning, and scaling-up of Safe Motherhood Promotional interventions in other geographical areas of Bangladesh as well as to inform other developing countries of similar settings.

Trial registration: NCT03032276 .

Keywords: Community, Cluster randomized controlled trial, Safe motherhood, Newborn survival.

Conflict of interest statement

Ethics approval and consent to participate

The ethical approval for conducting the study has been obtained from Institutional Review Board (IRB) of international centre for diarrhoeal diseases research, Bangladesh (icddr,b). An informed written consent form has been developed for this study. During the study, data collectors will approach and introduce themselves to the subject, explain the purpose of the visit, and read out the informed consent form to ask if the subject agrees to participate in the study. If the subject agrees and sign, then data collection process will be initiated. If the participant disagrees, she will still receive treatment as requested, with no data collected. All data collectors will receive training in research ethics. No compensation will be provided to the participants of the study and there is no foreseeable burden on the participants except the time required for the data collection. The study involves collecting personal identifiable information including name, age, gender, address. Participants will be assigned a unique identification number for aggregate data analysis, such that no identifiable data will be disseminated or published. Hard copies of data containing identifiable information will be kept securely locked in a cabinet in the office of co-investigators, and discarded ten years upon completion of the project. Access to the information will be limited only to the study personnel. Completed surveys will be transported in secured bags and opened for review in the central office. Once data collection is completed, personal identifiers will be removed from dataset before coding and analysis.

Consent for publication

As this is a study protocol, so we do not require consent of the study participants.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Conceptual Framework

Fig. 2

Study location