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
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, see Learn About Clinical Studies.

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 July 29, 2014