NCT01487707

Brief 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. 1.a Voluntary Health Worker Program (VHW)
  2. 2.the VHW program with provision of a safe birth kit
  3. 3.the VHW program with community folk media activities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

4.8 years

First QC Date

December 6, 2011

Last Update Submit

January 14, 2019

Conditions

Maternal Mortality

Keywords

pregnancymaternal mortalityneonatal mortalitycommunity interventionvoluntary health workersafe birth kitmaternal child health

Outcome Measures

Primary Outcomes (1)

  • Maternal Mortality Ratio

    42 days post delivery

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (3)

Voluntary Health Worker (VHW) Program

EXPERIMENTAL
Behavioral: Voluntary Health Worker (VHW) Program

VHW program plus Safe Birth Kit

EXPERIMENTAL
Behavioral: Voluntary Health Worker (VHW) ProgramBehavioral: Safe Birth Kit

VHW program plus Folk Media Activities

EXPERIMENTAL
Behavioral: Voluntary Health Worker (VHW) ProgramBehavioral: Community Folk Media Campaigns

Interventions

Voluntary Health Worker (VHW) ProgramBEHAVIORAL

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.

VHW program plus Folk Media ActivitiesVHW program plus Safe Birth KitVoluntary Health Worker (VHW) Program
Safe Birth KitBEHAVIORAL

A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.

VHW program plus Safe Birth Kit
Community Folk Media CampaignsBEHAVIORAL

Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.

VHW program plus Folk Media Activities

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Eligible women who do not consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood Federation

Abuja, Nigeria

Location

Related Publications (2)

  • Sharma V, Leight J, AbdulAziz F, Giroux N, Nyqvist MB. Illness recognition, decision-making, and care-seeking for maternal and newborn complications: a qualitative study in Jigawa State, Northern Nigeria. J Health Popul Nutr. 2017 Dec 21;36(Suppl 1):46. doi: 10.1186/s41043-017-0124-y.

    PMID: 29297412DERIVED

  • Sharma V, Brown W, Kainuwa MA, Leight J, Nyqvist MB. High maternal mortality in Jigawa State, Northern Nigeria estimated using the sisterhood method. BMC Pregnancy Childbirth. 2017 Jun 2;17(1):163. doi: 10.1186/s12884-017-1341-5.

    PMID: 28577546DERIVED

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jessica Leight, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

  • Vandana Sharma, MD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

  • Martina Bjorkman-Nyqvist, PhD

    Stockholm School of Economics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 7, 2011

Study Start

December 1, 2011

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

NG(1)