Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial

项目总结/文摘

Project Summary/Abstract This proposal, Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial, responds to PAR-16-160, and builds on our recent Fogarty International/NIH funded study (1 K01 TW008763-01A1, Lori PI) in Ghana. Our study is guided by a theoretical model originally developed by Squiers et al. and modified in our preliminary research to assess maternal health literacy. The Modified Maternal Health Literacy Skills Framework uses an ecological perspective to help assist in the development and testing of potential interventions to impact health literacy. Our intervention, group antenatal care (ANC), consists of grouping women by similar gestational ages into small groups at the first ANC visit. They then meet with the same group and the same provider over the course of their pregnancy. The model used to conduct the group visits was developed and tested among low- and non-literate pregnant women in Ghana by the PI with funding from Fogarty, in a quasi-experimental, two-group comparison study that yielded favorable behavioral outcomes. In this study, we propose three aims: Aim 1: To quantify differences in Birth Preparedness and Complication Readiness (BPCR), including knowledge of danger signs and recommended action steps between women randomized to group-based ANC and routine, individual ANC. Aim 2: To assess behavioral differences in care-seeking patterns (e.g. facility birth rates, postnatal and postpartum care) between women randomized to group-based ANC and routine, individual ANC. Aim 3: To evaluate the clinical outcomes of mothers and their newborns (e.g. decrease in maternal morbidities and perinatal and neonatal mortality) between women randomized to group-based ANC and routine, individual ANC immediately postpartum and up to one year following birth. We hypothesize that pregnant women randomized into group ANC will exhibit increased health literacy through: 1) increased BPCR including recognition of danger signs and knowledge of how to respond to such signs; 2) higher rates of care-seeking behaviors, including seeking care for problems identified during pregnancy, higher facility delivery rates, and increased attendance at postnatal care; and 3) better clinical outcomes for themselves and their newborns than women who received the standard, individual ANC. To test our hypotheses, we propose to conduct a cluster randomized control trial stratified by site and gestational age in the East Mamprusi District of the Northern Region of Ghana, a predominantly rural area. We will follow women and their newborns for one-year post delivery. To examine clinical and behavioral outcomes, data collection will be conducted via cellphones, face-to-face interviews, and medical record review. This study is significant and timely because it is one of the first randomized control trials to be conducted to examine the effects of group ANC with low and non-literate participants. Our findings have the potential to impact how clinical care is delivered to low literacy populations both globally and domestically to improve maternal and newborn outcomes.