Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03032276
Study type Interventional
Source International Centre for Diarrhoeal Disease Research, Bangladesh
Contact
Status Active, not recruiting
Phase N/A
Start date July 2016
Completion date July 2022

See also
  Status Clinical Trial Phase
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Not yet recruiting NCT04093778 - NEO-study, Newborn Emergency Outcome N/A
Active, not recruiting NCT03871491 - Azithromycin-Prevention in Labor Use Study (A-PLUS) Phase 3
Completed NCT03290924 - Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach N/A
Recruiting NCT05127070 - Evaluating the NeoTree in Malawi and Zimbabwe
Completed NCT02148952 - BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program N/A
Completed NCT03923023 - Impact of the PREEMI Package on Neonatal Mortality
Completed NCT03722615 - Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa
Completed NCT05369806 - Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya N/A
Recruiting NCT03577054 - Development of a Mobile Application for HBB Prompt Study N/A
Active, not recruiting NCT05854745 - Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia N/A
Recruiting NCT05763316 - Accuracy of Scoring Systems for Risk Assessment in Neonatal Intensive Care Unit
Recruiting NCT05714865 - Implementing LISA Surfactant in Nigeria Phase 4
Completed NCT01867749 - Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss N/A
Not yet recruiting NCT05763693 - Vitality in Infants Via Azithromycin for Neonates Trial Phase 4
Completed NCT03213509 - Verbal Autopsy of Maternal Deaths, Stillbirths, and Neonatal Deaths in BetterBirth
Enrolling by invitation NCT03438110 - Asia Pregnancy Outcomes Study
Completed NCT02999373 - Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates Phase 2
Completed NCT04311476 - Autologous Cord Blood Cells for Prevention of BPD in Preterm Phase 2
Completed NCT02605369 - SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan N/A