Safe Motherhood Promotion and Newborn Survival (SMPNS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03032276 |
Recruitment Status :
Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : February 11, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neonatal Death Maternal Death | Other: Safe motherhood and newborn health promotion package | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Impact and Operational Assessment of an Integrated Safe Motherhood and Newborn Health Promotion Package: a Community-based Cluster Randomized Controlled Trial |
Study Start Date : | July 2016 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | July 2022 |
Arm | Intervention/treatment |
---|---|
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).
|
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. |
No Intervention: Comparison
Another 15 union will be selected where no intervention will be implemented
|
- 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
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032276
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | International Centre for Diarrhoeal Disease Research, Bangladesh |
ClinicalTrials.gov Identifier: | NCT03032276 |
Other Study ID Numbers: |
PR-16013 |
First Posted: | January 26, 2017 Key Record Dates |
Last Update Posted: | February 11, 2022 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Safe motherhood Newborn survival Community Cluster Randomized Trial |
Perinatal Death Maternal Death Death |
Pathologic Processes Pregnancy Complications Parental Death |