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Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

Primary Purpose

Maternal Mortality

Status

Completed

Phase

Not Applicable

Locations

Nigeria

Study Type

Interventional

Intervention

Voluntary Health Worker (VHW) Program

Safe Birth Kit

Community Folk Media Campaigns

About this trial

This is an interventional prevention trial for Maternal Mortality focused on measuring pregnancy, maternal mortality, neonatal mortality, community intervention, voluntary health worker, safe birth kit, maternal child health

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Eligible women who do not consent.

Sites / Locations

Planned Parenthood Federation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Voluntary Health Worker (VHW) Program

VHW program plus Safe Birth Kit

VHW program plus Folk Media Activities

Arm Description

Outcomes

Primary Outcome Measures

Maternal Mortality Ratio

Secondary Outcome Measures

Maternal Morbidity Rates

Proportion of women delivering in a health facility

Neonatal Mortality Rate

Proportion of women receiving antenatal care during pregnancy

Knowledge of warning signs during pregnancy

Proportion of women/newborns receiving postnatal care

Birthweight

Stunting, underweight and wasting in children under 5 years

Full Information

NCT ID

NCT01487707

First Posted

December 6, 2011

Last Updated

January 14, 2019

Sponsor

Abdul Latif Jameel Poverty Action Lab

Collaborators

Planned Parenthood Federation Nigeria, MacArthur Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01487707

Brief Title

Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

Official Title

Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abdul Latif Jameel Poverty Action Lab

Collaborators

Planned Parenthood Federation Nigeria, MacArthur Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Maternal Mortality

Keywords

pregnancy, maternal mortality, neonatal mortality, community intervention, voluntary health worker, safe birth kit, maternal child health

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Voluntary Health Worker (VHW) Program

Arm Type

Experimental

Arm Title

VHW program plus Safe Birth Kit

Arm Type

Experimental

Arm Title

VHW program plus Folk Media Activities

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Voluntary Health Worker (VHW) Program

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Safe Birth Kit

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Community Folk Media Campaigns

Intervention Description

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

Primary Outcome Measure Information:

Title

Maternal Mortality Ratio

Time Frame

42 days post delivery

Secondary Outcome Measure Information:

Title

Maternal Morbidity Rates

Time Frame

42 days post delivery

Title

Proportion of women delivering in a health facility

Time Frame

2 years

Title

Neonatal Mortality Rate

Time Frame

28 days after birth

Title

Proportion of women receiving antenatal care during pregnancy

Time Frame

2 years

Title

Knowledge of warning signs during pregnancy

Time Frame

2 years

Title

Proportion of women/newborns receiving postnatal care

Time Frame

2 years

Title

Birthweight

Time Frame

2 years

Title

Stunting, underweight and wasting in children under 5 years

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica Leight, PhD

Organizational Affiliation

Massachusetts Institute of Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vandana Sharma, MD

Organizational Affiliation

Massachusetts Institute of Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martina Bjorkman-Nyqvist, PhD

Organizational Affiliation

Stockholm School of Economics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Planned Parenthood Federation

City

Abuja

Country

Nigeria

12. IPD Sharing Statement

Citations:

PubMed Identifier

29297412

Citation

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.

Results Reference

derived

PubMed Identifier

28577546

Citation

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.

Results Reference

derived

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Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

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