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

Primary Purpose

Antenatal Care and Delivery

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Incentives
Community
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Antenatal Care and Delivery focused on measuring Maternal Health, Maternal Mortality, Global Health, RCT

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Other

    Arm Description

    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.

    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

    Outcomes

    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.

    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.

    Full Information

    First Posted
    December 28, 2015
    Last Updated
    December 30, 2015
    Sponsor
    University of Ottawa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02643953
    Brief Title
    Increasing Women's Access to Skilled Pregnancy Care to Reduce Maternal Mortality in Nigeria
    Official Title
    Increasing Women's Access to Skilled Pregnancy Care to Reduce Maternal and Perinatal Mortality in Nigeria: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    January 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Ottawa

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Antenatal Care and Delivery
    Keywords
    Maternal Health, Maternal Mortality, Global Health, RCT

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Other
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Incentives
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Community
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria 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. Women who have antenatal care record at one of the study facilities Exclusion Criteria Women outside the research regions who fail to meet any of the inclusion criteria will be excluded Women who do not have an antenatal care record at one of the study facilities

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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