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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 : August 20, 2019
Sponsor:
Collaborators:
Government of Bangladesh
Tokyo University
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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

Condition or disease Intervention/treatment Phase
Neonatal Death Maternal Death Other: Safe motherhood and newborn health promotion package Not Applicable

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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 : December 2019
Estimated Study Completion Date : December 2019

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Government of Bangladesh
Tokyo University
Investigators
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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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03032276    
Other Study ID Numbers: 16013
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Safe motherhood
Newborn survival
Community
Cluster Randomized Trial
Additional relevant MeSH terms:
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Perinatal Death
Maternal Death
Death
Pathologic Processes
Pregnancy Complications
Parental Death