Antenatal Care and Delivery Clinical Trial
Official title:
Increasing Women's Access to Skilled Pregnancy Care to Reduce Maternal and Perinatal Mortality in Nigeria: A Randomized Control Trial
Verified date | December 2015 |
Source | University of Ottawa |
Contact | n/a |
Is FDA regulated | No |
Health authority | Nigeria: Federal Ministry of Health |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | January 2021 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Ottawa |
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 48 months | No | |
Secondary | A secondary outcome will be the proportion of women giving birth and attending PHCs who have received standard/quality antenatal, intrapartum and postnatal care. | Up to 48 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01409824 -
Health Care Intervention Research- Improving Pre-natal and Maternal Care
|
N/A |