Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Planned Parenthood Federation Nigeria
MacArthur Foundation
Information provided by (Responsible Party):
Abdul Latif Jameel Poverty Action Lab
ClinicalTrials.gov Identifier:
NCT01487707
First received: December 6, 2011
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.

Condition Intervention
Maternal Mortality
Behavioral: Voluntary Health Worker (VHW) Program
Behavioral: Safe Birth Kit
Behavioral: Community Folk Media Campaigns

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria

Further study details as provided by Abdul Latif Jameel Poverty Action Lab:

Primary Outcome Measures:
  • Maternal Mortality Ratio [ Time Frame: 42 days post delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal Morbidity Rates [ Time Frame: 42 days post delivery ] [ Designated as safety issue: No ]
  • Proportion of women delivering in a health facility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Neonatal Mortality Rate [ Time Frame: 28 days after birth ] [ Designated as safety issue: No ]
  • Proportion of women receiving antenatal care during pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Knowledge of warning signs during pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportion of women/newborns receiving postnatal care [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Birthweight [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Stunting, underweight and wasting in children under 5 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 7200
Study Start Date: December 2011
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Eligible women who do not consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487707

Locations
Nigeria
Planned Parenthood Federation
Abuja, Nigeria
Sponsors and Collaborators
Abdul Latif Jameel Poverty Action Lab
Planned Parenthood Federation Nigeria
MacArthur Foundation
Investigators
Principal Investigator: Jessica Leight MIT
Principal Investigator: Vandana Sharma, MD MIT
Principal Investigator: Martina Bjorkman-Nyqvist, PhD Stockholm School of Economics
  More Information

No publications provided

Responsible Party: Abdul Latif Jameel Poverty Action Lab
ClinicalTrials.gov Identifier: NCT01487707     History of Changes
Other Study ID Numbers: 019368-001
Study First Received: December 6, 2011
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abdul Latif Jameel Poverty Action Lab:
pregnancy
maternal mortality
neonatal mortality
community intervention
voluntary health worker
safe birth kit
maternal child health

ClinicalTrials.gov processed this record on April 17, 2014