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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01487707
Other study ID # 019368-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2011
Est. completion date October 2016

Study information

Verified date January 2019
Source Abdul Latif Jameel Poverty Action Lab
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 7200
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility Inclusion Criteria:

- Women of reproductive age who live in the study clusters who provide consent.

Exclusion Criteria:

- Eligible women who do not consent.

Study Design


Related Conditions & MeSH terms


Intervention

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.
Safe Birth Kit
A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.
Community Folk Media Campaigns
Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.

Locations

Country Name City State
Nigeria Planned Parenthood Federation Abuja

Sponsors (3)

Lead Sponsor Collaborator
Abdul Latif Jameel Poverty Action Lab MacArthur Foundation, Planned Parenthood Federation Nigeria

Country where clinical trial is conducted

Nigeria, 

Outcome

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