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Safe Motherhood Promotion and Newborn Survival (SMPNS)

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ClinicalTrials.gov Identifier: NCT03032276
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : February 9, 2021
Sponsor:
Collaborators:
Government of Bangladesh
Tokyo University
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information
First Submitted Date  ICMJE January 11, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date February 9, 2021
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Reduction of neonatal mortality rate (NMR) [ Time Frame: 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 ]
NMR will be assessed at the beginning of the project. after that it will also assessed by two midline assessment after starting the intervention and finally it will be assessed during the endline survey
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Changes in coverage and utilization of maternal and newborn health services [ Time Frame: At year 1 (baseline), year 2 and 3 (mid lines) and year 4 (end line) ]
    This will be assessed to evaluate the effect of the comprehensive package of interventions on health and care seeking behavior for neonates and women during antepartum, intrapartum and postpartum period at baseline and end line survey on total population and during two mid line surveys in a sub set of population
  • Cost effectiveness of implementing the interventions [ Time Frame: Every six months for programme costs ]
    Costs for improved neonatal health outcomes and related health services. This will be assessed by analyzing Costs per DALY averted, Costs per life-year gained; Costs per case of delivery by skilled attendance; Costs per case of essential neonatal care, Program cost, both start up and post implementation, Incremental health service costs for providing quality services, Out of pocket expenditure etc.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safe Motherhood Promotion and Newborn Survival
Official Title  ICMJE Impact and Operational Assessment of an Integrated Safe Motherhood and Newborn Health Promotion Package: a Community-based Cluster Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Neonatal Death
  • Maternal Death
Intervention  ICMJE Other: Safe motherhood and newborn health promotion package
The intervention package consists of three components: facility, community and linkages between the community and health facilities. Facility based interventions will serve both the comparison and intervention arms. However, other two interventions will serve the intervention arm only. Specific interventions and approaches for the three components will be implemented within the MOH&FW service delivery system to improve MNH practices in families and communities and to increase the use of MNH services from appropriate facilities/providers. The intervention package has been developed based on the experiences from SMPP in Narsingdi district and on the basis of consultations with the International Advisory Body (IAB) that included GoB, JICA, ICDDR,B, other experts and stakeholders.
Study Arms  ICMJE
  • Experimental: Intervention
    "'Safe motherhood and newborn health promotion package'" will be implemented in the intervention arm which comprise 15 randomly selected unions (lowest level of administrative unit).
    Intervention: Other: Safe motherhood and newborn health promotion package
  • No Intervention: Comparison
    Another 15 union will be selected where no intervention will be implemented
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
50400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032276
Other Study ID Numbers  ICMJE 16013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party International Centre for Diarrhoeal Disease Research, Bangladesh
Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators  ICMJE
  • Government of Bangladesh
  • Tokyo University
Investigators  ICMJE
Principal Investigator: Shams El Arifeen, DrPH, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: D M Emdadul Hoque, MPH, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Sanwarul Bari, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Masum Billah, MPH, BURP International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Ahmed Ehsanur Rahman, MPH, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Tazeen Tahsina, MS Economics International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Mohiuddin Ahsanul Kabir Chowdhury, MPH, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Mohammad Mehedi Hasan, MPH, MSc International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Sajia Islam, MPH, BDS International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Mohammad Masudur Rahman, MPS, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Nazia Binte Ali, MPH, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh
Study Director: Jasmin Khan, MPH, MSS International Centre for Diarrhoeal Disease Research, Bangladesh
PRS Account International Centre for Diarrhoeal Disease Research, Bangladesh
Verification Date January 2021

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