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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01409824 -
Health Care Intervention Research- Improving Pre-natal and Maternal Care
|
N/A |