Clinical trial NCT03032276: Safe Motherhood Promotion and Newborn Survival
Official title: Impact and Operational Assessment of an Integrated Safe Motherhood and Newborn Health Promotion Package: a Community-based Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Death
Maternal Death
Keywords: Safe motherhood
Newborn survival
Community
Cluster Randomized Trial
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Government of Bangladesh
name: Tokyo University
First posted: 2017-01-26
Enrollment: 50400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Primary objective of the study is to measure the impact of a comprehensive package of interventions introduced by the Safe Motherhood Promotion and Newborn Survival project on neonatal mortality in three Upazila of Chandpur district, Bangladesh

Detailed description: Burden: Globally around 6.3 million children under five years of age died in 2013, two third of which occur in the low \& middle income countries. Bangladesh is one of the LMICs countries with high burden of maternal and neonatal mortalities. In Bangladesh, there has been a considerable progress in reduction of both child and maternal mortality in recent decades. From 1994 to 2014 under-5 mortality rate has reduced from 133 to 46 per 1000 live births in Bangladesh; however, within the same timeframe neonatal mortality declined from 52 to 28 per 1000 live births. This slow decrease in newborn deaths means that it now constitutes a greater share of total under-5 deaths. At present, neonatal mortality accounts for 74% of deaths in infants and 61% in children aged less than 5 years. Similarly, the country was able to decline MMR by 70% between 1990 and 2013, from 574 to 170 per 100,000 live births, with an annual reduction rate of 5.0%. Such statistics highlights the importance of focusing on perinatal and early postnatal periods to prevent maternal and neonatal mortalities.

Knowledge gap: Safe motherhood promotion project (SMPP) was a five (5 yr) year pilot project, launched in July 2006, by the Government of Bangladesh (GOB) in collaboration with JICA. The aim of the project was to improve the health status of pregnant and postpartum women and neonates. SMPP implemented three linked activities i.e., advocacy at the central level, strengthening of health facilities and empowerment of community. Evaluation of SMPP found positive changes in UN process indicators on EmOC including met needs (up from 31% to 55%), case fatality rate (\<0.1%) and skilled birth attendance rate (from 18% to 25%). The major weakness of the previous assessment of SMPP were use of a before-after design without any concurrent comparison area and the assessment lacked population based mortality estimates, only measured hospital case fatality rate. Hence, there is lack of strong evidences regarding the impact of the project.

Relevance: The proposed project is expected to provide essential evidences to the GOB and other development partners with the help of stronger design and valid evaluation processes. It would help not only in prioritizing, planning, and further scaling-up of SMPNS interventions in other areas of Bangladesh but in informing other developing countries in similar settings also.

Hypothesis: Safe Motherhood and Newborn Survival intervention package will reduce neonatal mortality by 25%, in comparison to the routine services in Chandpur district, Bangladesh

Methods: A community-based, cluster-randomized design will be used to evaluate the effectiveness of an integrated "Safe Motherhood and Newborn Health Promotion Package" in Chandpur district, Bangladesh. Both quantitative and qualitative approaches will be employed to address the primary and secondary objectives. Baseline, midterm and end of intervention household survey will be conducted using validated structured questionnaire to assess the coverage of maternal \& newborn health interventions. Health facility assessments surveys will be conducted periodically to assess facility readiness and utilization of maternal and neonatal health services in the participating health facilities. Additionally, relevant data from routine Health Management Information System (HMIS) will be regularly collected and extracted An ongoing investigating system will be in place at the health facilities to identify and document maternal near miss cases.

Qualitative data will be collected for process documentation and in depth exploration of implementation challenges and contextual factors. Social capitals will be measured both quantitatively and qualitatively to assess the non health impact of the interventions. Qualitative data collection methods will include stakeholders' meeting, focus group discussions (FGD), periodic in-depth assessments, social mapping and other participatory exercises.

Outcome measures/variables: The primary outcome measure for evaluation of SMPNS intervention is reduction of neonatal mortality. In addition, changes in coverage and utilization of maternal \& newborn health services, cost effectiveness of implementation of intervention will also be measured.

Eligibility criteria: Inclusion Criteria:

* Women with birth outcome in last three years

Exclusion Criteria:

* Unusual unions as per the contextual factors (demographics, terrain, functionality of health services, etc.) will be excluded.
* If a union has a total population of less than 12,000 (the minimum required to get adequate sample of neonates) they will either be excluded

Primary outcomes:
measure: Reduction of neonatal mortality rate (NMR)
timeFrame: During baseline at year 1, in two mid-line at year 2 & 3 and finally after completion of the of the intervention at year 4
Secondary outcomes:
measure: Changes in coverage and utilization of maternal and newborn health services
timeFrame: At year 1 (baseline), year 2 and 3 (mid lines) and year 4 (end line)
measure: Cost effectiveness of implementing the interventions
timeFrame: Every six months for programme costs
Other outcomes:
Locations:
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Shams El Arifeen, DrPH, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: D M Emdadul Hoque, MPH, MBBS
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Sanwarul Bari, MBBS
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Masum Billah, MPH, BURP
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Ahmed Ehsanur Rahman, MPH, MBBS
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Tazeen Tahsina, MS Economics
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Mohiuddin Ahsanul Kabir Chowdhury, MPH, MBBS
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Mohammad Mehedi Hasan, MPH, MSc
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Sajia Islam, MPH, BDS
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Mohammad Masudur Rahman, MPS, MBBS
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Nazia Binte Ali, MPH, MBBS
role: STUDY_DIRECTOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Jasmin Khan, MPH, MSS
role: STUDY_DIRECTOR
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