Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

January 14, 2019 updated by: Abdul Latif Jameel Poverty Action Lab

Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria

The objective of this cluster randomized controlled trial is to assess the impact of several community-based interventions that address the key factors underlying the high maternal mortality, as well as neonatal mortality and morbidity in northern Nigeria. The interventions, include:

  1. a Voluntary Health Worker Program (VHW)
  2. the VHW program with provision of a safe birth kit
  3. the VHW program with community folk media activities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Abuja, Nigeria
        • Planned Parenthood Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women of reproductive age who live in the study clusters who provide consent.

Exclusion Criteria:

  • Eligible women who do not consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Voluntary Health Worker (VHW) Program
Behavioral: Voluntary Health Worker (VHW) Program
Voluntary Health Workers will conduct door-to-door campaigns on maternal and child health, and will visit pregnant women regularly to to educate and to encourage use of antenatal care and facility-based deliveries.
Experimental: VHW program plus Safe Birth Kit
Behavioral: Voluntary Health Worker (VHW) Program
Voluntary Health Workers will conduct door-to-door campaigns on maternal and child health, and will visit pregnant women regularly to to educate and to encourage use of antenatal care and facility-based deliveries.
Behavioral: Safe Birth Kit
A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.
Experimental: VHW program plus Folk Media Activities
Behavioral: Voluntary Health Worker (VHW) Program
Voluntary Health Workers will conduct door-to-door campaigns on maternal and child health, and will visit pregnant women regularly to to educate and to encourage use of antenatal care and facility-based deliveries.
Behavioral: Community Folk Media Campaigns
Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maternal Mortality Ratio
Time Frame: 42 days post delivery
42 days post delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal Morbidity Rates
Time Frame: 42 days post delivery
42 days post delivery
Proportion of women delivering in a health facility
Time Frame: 2 years
2 years
Neonatal Mortality Rate
Time Frame: 28 days after birth
28 days after birth
Proportion of women receiving antenatal care during pregnancy
Time Frame: 2 years
2 years
Knowledge of warning signs during pregnancy
Time Frame: 2 years
2 years
Proportion of women/newborns receiving postnatal care
Time Frame: 2 years
2 years
Birthweight
Time Frame: 2 years
2 years
Stunting, underweight and wasting in children under 5 years
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abdul Latif Jameel Poverty Action Lab

Collaborators

MacArthur Foundation
Planned Parenthood Federation Nigeria

Investigators

  • Principal Investigator: Jessica Leight, PhD, Massachusetts Institute of Technology
  • Principal Investigator: Vandana Sharma, MD, Massachusetts Institute of Technology
  • Principal Investigator: Martina Bjorkman-Nyqvist, PhD, Stockholm School of Economics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 019368-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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