Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria
Last registered on September 07, 2016

Pre-Trial

Trial Information
General Information
Title
Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria
RCT ID
AEARCTR-0000006
Initial registration date
May 26, 2013
Last updated
September 07, 2016 5:44 PM EDT
Location(s)
Region
Primary Investigator
Affiliation
IFPRI
Other Primary Investigator(s)
PI Affiliation
Stockholm School of Economics
PI Affiliation
MIT
Additional Trial Information
Status
Completed
Start date
2012-02-01
End date
2015-12-31
Secondary IDs
ClinicalTrials.gov ID: NCT01487707
Abstract
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.
External Link(s)
Registration Citation
Citation
Leight, Jessica, Martina Nyqvist and Vandana Sharma. 2016. "Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria." AEA RCT Registry. September 07. https://doi.org/10.1257/rct.6-2.0.
Former Citation
Leight, Jessica et al. 2016. "Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria." AEA RCT Registry. September 07. http://www.socialscienceregistry.org/trials/6/history/10566.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
The study will be evaluating 3 primarily demand side community-based interventions aimed at increasing utilization of health care services offered at existing facilities in Jigawa state. Specifically, the following interventions are being evaluated:

Intervention 1: 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 educate and to encourage use of antenatal care and facility-based deliveries.

Intervention 2: VHW program plus distribution of Safe Birth Kits
Communities in this arm will receive the standard package of VHW services supplemented with distribution of safe birth kits to pregnant women. Safe birth kits contain sterile materials to diminish infection risk during delivery.

Intervention 3: VHW program plus Community Engagement Strategies
In addition to the VHW program, communities in this arm will Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.
Intervention Start Date
2013-06-01
Intervention End Date
2015-06-01
Primary Outcomes
Primary Outcomes (end points)
Maternal Mortality Ratio (MMR), Neonatal Mortality Rate (NMR), Maternal Morbidity, birthweight, health seeking behaviour
Primary Outcomes (explanation)

Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The study is a clustered randomized controlled field trial and is taking place in 24 Local Government Areas (LGAs) in Jigawa State Nigeria. 96 clusters of villages with a population of close to 300,000 inhabitants have been included in the study. 24 clusters of villages have been randomly assigned to one of the 4 study arms (3 treatment arms and 1 control arm). Fifteen percent of households with women of reproductive age have been sampled to take part in a baseline survey prior to implementation of the interventions. These same households will participate in an endline survey, two years after initiation of the interventions. According to population estimates, approximately 7,200 women will be surveyed as part of the baseline and endline surveys.

In addition, all pregnant women in the households sampled for the baseline survey will be asked to participate in post partum surveys (one within 72 hours after birth, and the other 4 weeks after birth) during the 2-year program implementation phase. Approximately 3,500 post-partum women will be surveyed as part of these surveys.

Monitors will also keep track of all deaths of women of reproductive age and neonatal deaths in their respective villages via an SMS monitoring system.
Experimental Design Details
Randomization Method
Randomization was done in an office outside of the study area by computer.
Randomization Unit
clusters of villages with an average population size of 3,000 inhabitants
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
96 clusters of villages
Sample size: planned number of observations
7200 women
Sample size (or number of clusters) by treatment arms
24 clusters per study arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Massachusetts Institute of Technology
IRB Approval Date
2011-12-01
IRB Approval Number
1011004168
IRB Name
IPA
IRB Approval Date
2011-03-05
IRB Approval Number
429.11May-001
Analysis Plan

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Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers