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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Increasing Women's Access to Skilled Pregnancy Care to Reduce Maternal and Perinatal Mortality in Nigeria: A Randomized Control Trial

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 si

Detailed Summary:

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 inter
Sponsor: University of Ottawa

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: University of Ottawa

Dates:
Date Received: December 28, 2015
Date Started: January 2016
Date Completion: January 2021
Last Updated: December 30, 2015
Last Verified: December 2015