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Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

Last registered on September 07, 2016
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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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 26, 2013, 10:40 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
September 07, 2016, 5:44 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
Nigeria
Region
Africa

Primary Investigator

Name
Jessica Leight
Affiliation
IFPRI
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Other Primary Investigator(s)

PI Name
Martina Bjorkman Nyqvist
PI Affiliation
Stockholm School of Economics
Contact Investigator
PI Name
Vandana Sharma
PI Affiliation
MIT
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Additional Trial Information

Status
Completed
Start date
2012-02-01
End date
2015-12-31
Keywords
Health
Additional Keywords
pregnancy, maternal mortality, neonatal mortality, community intervention, voluntary health worker, safe birth kit, maternal child health
JEL code(s)
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 Bjorkman 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, Martina Bjorkman Nyqvist and Vandana Sharma. 2016. "Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria." AEA RCT Registry. September 07. https://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)
Supporting Documents and Materials
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

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials