Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria
This study is ongoing, but not recruiting participants.
Sponsor:
Abdul Latif Jameel Poverty Action Lab
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
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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:
- a Voluntary Health Worker Program (VHW)
- the VHW program with provision of a safe birth kit
- 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 May 16, 2013