Overview

This trial is active, not recruiting.

Condition maternal mortality
Treatments voluntary health worker (vhw) program, safe birth kit, community folk media campaigns
Sponsor Abdul Latif Jameel Poverty Action Lab
Collaborator Planned Parenthood Federation Nigeria
Start date December 2011
End date June 2016
Trial size 7200 participants
Trial identifier NCT01487707, 019368-001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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)
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.
safe birth kit
A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.
(Experimental)
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.
community folk media campaigns
Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.

Primary Outcomes

Measure
Maternal Mortality Ratio
time frame: 42 days post delivery

Secondary Outcomes

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

Eligibility Criteria

Female participants from 15 years up to 49 years old.

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

Additional Information

Official title Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria
Principal investigator Jessica Leight, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Abdul Latif Jameel Poverty Action Lab.