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Increasing Women's Access to Skilled Pregnancy Care to Reduce Maternal Mortality in Nigeria

This study is not yet open for participant recruitment.
Verified December 2015 by Sanni Yaya, University of Ottawa
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643953
First Posted: December 31, 2015
Last Update Posted: December 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanni Yaya, University of Ottawa
  Purpose

Background: Nigeria has the second highest absolute number of maternal deaths and perinatal deaths in the world. The country contributes 14% of all maternal deaths worldwide, second only to India. Although all parts of the country are affected, most maternal, and perinatal deaths occur in the northeast and northwest geo-political zones, where women have limited access to evidence-based maternal and newborn health services. Affected women and families are mainly those who have little or no formal education, who are poor and marginalized, and who live in rural and sub-urban communities.

Problem: Research carried out in various regions of Nigeria has shown that insufficient access to pregnancy health services is a major factor that places women at high risk of adverse maternal and perinatal outcomes. Maternal care provided within Nigeria's numerous local Primary Health Centres (PHCs) is an efficient and practical avenue for reaching vulnerable women and their newborn infants, and PHC use is strongly encouraged by the Nigerian Federal Ministry of Health.

Research Question and Objective: The key research question and objectives are as follows: 1) To determine the main factors that prevent vulnerable women from using PHCs or receiving maternal and neonatal care therein; 2) To identify effective community level interventions for improving women's access to maternal health services, as a means to reduce maternal and perinatal morbidity and mortality in Nigeria.

Methodology: This study will complete a community-based, multi-site project using a mixed methods approach. The project will be done in three sequential phases: A data gathering phase (Phase 1), an intervention phase (Phase 2), and the implementation of the findings (Phase 3). The study will be conducted over 54-months in six communities, and another six communities of similar status will serve as control sites. During Phases 1-3, surveys about maternal health services utilization will be carried out at baseline, midterm and completion points of the project.

Potential Impact: Increasing women's access to evidence-based maternity care is likely a direct way to reduce maternal and neonatal mortality in Nigeria. The proposed project will determine how we can effectively increase access to PHCs, and then bring those findings into a policy and program format that can be applied across the country.


Condition Intervention
Antenatal Care and Delivery Behavioral: Incentives Behavioral: Community

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Women's Access to Skilled Pregnancy Care to Reduce Maternal and Perinatal Mortality in Nigeria: A Randomized Control Trial

Further study details as provided by Sanni Yaya, University of Ottawa:

Primary Outcome Measures:
  • The main outcome variable will be the proportion of women, among those who give birth following the start of the intervention, who use PHCs for antenatal, delivery and postnatal care, in the intervention and control health wards. [ Time Frame: Up to 48 months ]

Secondary Outcome Measures:
  • A secondary outcome will be the proportion of women giving birth and attending PHCs who have received standard/quality antenatal, intrapartum and postnatal care. [ Time Frame: Up to 48 months ]

Estimated Enrollment: 100
Study Start Date: January 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
This arm includes women who are eligible and give birth (including cases of fetal or infant death) in the intervention period in comparative health wards, who will not receive the interventions and who will continue to receive their usual pattern of utilization of maternity care.
Experimental: Other
The intervention will need to be multi-faceted, and will consist of provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; conditional cash transfers to promote uptake of services and targeted community health education and advocacy activities
Behavioral: Incentives
1) provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; 2) conditional cash transfers to promote uptake of services; 3) targeted community health education and advocacy activities; 4) community maternal audit/accountability activities, with community-led activities aimed at promoting utilization of services
Behavioral: Community
1) outreach services by PHCs; 6) PHC strengthening including training of health providers; and 2) training and kitting of community health rangers who will be trained to follow up women at home to ensure that they do not default but that they continue to use PHC services until delivery.

Detailed Description:

Intervention Design: This intervention will be a randomized cluster trial design: interventions will be implemented in 6 health wards/communities (4 rural/peri-urban and 2 urban) while 6 health wards/communities with similar socio-demographic characteristics will serve as controls (where the intervention is not implemented). Including some urban or peri-urban clusters enables one to capture both rural and urban data about attitudes toward PMC maternal care (Phase 1), and the efficacy of the intervention to increase PMC use (Phase 2). It also enables one to see if attitudes (Phase 1 data) and the intervention (Phase 2) are different in rural vs. urban settings. This would be described as being a secondary analysis of the main data derived during Phase 1 and Phase 2.

The Intervention: The actual intervention activities to be applied will be finalized after the intervention workshop, following Phase 1. However, based on current knowledge, the intervention will need to be multi-faceted, and will possibly consist of 1) provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; 2) conditional cash transfers to promote uptake of services; 3) targeted community health education and advocacy activities; 4) community maternal audit/accountability activities, with community-led activities aimed at promoting utilization of services; 5) outreach services by PHCs; 6) PHC strengthening including training of health providers; and 7) training and kitting of community health rangers who will be trained to follow up women at home to ensure that they do not default but that they continue to use PHC services until delivery.

Control Group: The control group will comprise women who are eligible and give birth (including cases of fetal or infant death) in the intervention period in comparative health wards, who will not receive the interventions and who will continue to receive their usual pattern of utilization of maternity care. To ensure comparability of social, economic and cultural factors between the intervention and control groups, the health wards that will serve as controls will have been selected from the same States as the intervention health wards. Hence, the study will have paired intervention-control groups from the same States, but distanced enough from one another (in separate LGAs) to reduce the potential effects of study contamination (i.e., the intervention is known or adopted in a control region). However, should the intervention prove to be effective, the investigators will be recommending the use of the same intervention activities in the control sites, as well as throughout the country.

  Eligibility

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Women who give birth (including cases of foetal or infant death) in comparative health wards and who receive their usual pattern of utilization of maternity care.
  2. Women who have antenatal care record at one of the study facilities

Exclusion Criteria

  1. Women outside the research regions who fail to meet any of the inclusion criteria will be excluded
  2. Women who do not have an antenatal care record at one of the study facilities
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Sanni Yaya, Associate Professor, University of Ottawa
ClinicalTrials.gov Identifier: NCT02643953     History of Changes
Other Study ID Numbers: 108041
First Submitted: December 28, 2015
First Posted: December 31, 2015
Last Update Posted: December 31, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sanni Yaya, University of Ottawa:
Maternal Health
Maternal Mortality
Global Health
RCT

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