Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

Study Overview
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Brief Summary
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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.

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

Conditions
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Maternal Mortality

Intervention / Treatment
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* Behavioral: Voluntary Health Worker (VHW) Program
* Behavioral: Safe Birth Kit
* Behavioral: Community Folk Media Campaigns


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of reproductive age who live in the study clusters who provide consent. Exclusion Criteria: Eligible women who do not consent.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voluntary Health Worker (VHW) Program<br> | Behavioral: Voluntary Health Worker (VHW) Program<br>* 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.<br>|
| Experimental: VHW program plus Safe Birth Kit<br> | Behavioral: Voluntary Health Worker (VHW) Program<br>* 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.<br>Behavioral: Safe Birth Kit<br>* A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.<br>|
| Experimental: VHW program plus Folk Media Activities<br> | Behavioral: Voluntary Health Worker (VHW) Program<br>* 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.<br>Behavioral: Community Folk Media Campaigns<br>* Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Mortality Ratio |  | 42 days post delivery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal mortality, pregnancy, maternal mortality, community intervention, voluntary health worker, safe birth kit, maternal child health