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Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria

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ClinicalTrials.gov Identifier: NCT01487707
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : July 14, 2017
Sponsor:
Collaborators:
Planned Parenthood Federation Nigeria
MacArthur Foundation
Information provided by (Responsible Party):
Abdul Latif Jameel Poverty Action Lab

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. 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.

Condition or disease Intervention/treatment Phase
Maternal Mortality Behavioral: Voluntary Health Worker (VHW) Program Behavioral: Safe Birth Kit Behavioral: Community Folk Media Campaigns Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Strengthening the Midwife Service Scheme With Community Focused Interventions: Evidence From a Randomized Controlled Field Trial in Nigeria
Study Start Date : December 2011
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Voluntary Health Worker (VHW) Program 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.
Experimental: VHW program plus Safe Birth Kit 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.
Behavioral: Safe Birth Kit
A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.
Experimental: VHW program plus Folk Media Activities 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.
Behavioral: Community Folk Media Campaigns
Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.



Primary Outcome Measures :
  1. Maternal Mortality Ratio [ Time Frame: 42 days post delivery ]

Secondary Outcome Measures :
  1. Maternal Morbidity Rates [ Time Frame: 42 days post delivery ]
  2. Proportion of women delivering in a health facility [ Time Frame: 2 years ]
  3. Neonatal Mortality Rate [ Time Frame: 28 days after birth ]
  4. Proportion of women receiving antenatal care during pregnancy [ Time Frame: 2 years ]
  5. Knowledge of warning signs during pregnancy [ Time Frame: 2 years ]
  6. Proportion of women/newborns receiving postnatal care [ Time Frame: 2 years ]
  7. Birthweight [ Time Frame: 2 years ]
  8. Stunting, underweight and wasting in children under 5 years [ Time Frame: 2 years ]


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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Eligible women who do not consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487707


Locations
Nigeria
Planned Parenthood Federation
Abuja, Nigeria
Sponsors and Collaborators
Abdul Latif Jameel Poverty Action Lab
Planned Parenthood Federation Nigeria
MacArthur Foundation
Investigators
Principal Investigator: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abdul Latif Jameel Poverty Action Lab
ClinicalTrials.gov Identifier: NCT01487707     History of Changes
Other Study ID Numbers: 019368-001
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Abdul Latif Jameel Poverty Action Lab:
pregnancy
maternal mortality
neonatal mortality
community intervention
voluntary health worker
safe birth kit
maternal child health

Additional relevant MeSH terms:
Maternal Death
Pregnancy Complications
Parental Death
Death
Pathologic Processes