Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 14, 2022
Open Peer Review Period: Jul 6, 2022 - Jul 21, 2022
Date Accepted: Jul 30, 2022
(closed for review but you can still tweet)
Group Antenatal Care: A Cluster Randomized Controlled Trial
ABSTRACT
Background:
While group antenatal care has been delivered and studied in high-income countries for over a decade, it has only recently been introduced as an alternative to individual care in sub-Saharan Africa. Although the experimental design of the studies from high-resource countries are scientifically rigorous, findings cannot be generalized to low-resource countries with low literacy rates and high rates of maternal and newborn morbidity and mortality. The GRoup ANtenatal care Delivery project (GRAND) is a collaboration between University of Michigan in the United States and the Dodowa Health Research Center in Ghana. GRAND is a five-year, cluster randomized controlled trial. Our intervention, group antenatal care, consists of grouping women by similar gestational ages into small groups at the first antenatal care visit. They then meet with the same group and the same midwife at the recommended intervals for care.
Objective:
This study aims to improve health literacy, increase birth preparedness and complication readiness, and optimize maternal and newborn outcomes among women attending antenatal care at 7 rural health facilities in the Eastern region of Ghana.
Methods:
Quantitative data will be collected at four time points using a secure web application for data collection and database management tool. Data will be analyzed on an intention-to-treat basis to test the differences between the two arms; women randomized to group-based antenatal care and women randomized to routine, individual antenatal care. We will concurrently conduct a process evaluation to identify and document patient, provider, and system barriers and facilitators to program implementation.
Results:
The study was funded in September 2018. Recruitment and enrollment of participants and data collection started in July 2019. In November 2021, we completed enrollment in the study (n=1761) and in May 2022 data collection for third trimester finished (n=1284). Data collection at the additional three time points: postpartum, 6-months and 1-year postpartum continues.
Conclusions:
This study is significant and timely because it is among the first randomized control trials to be conducted to examine the effects of group antenatal care 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. Clinical Trial: ClinicalTrials.gov Identifier: NCT04033003, Registered: July 25, 2019, https://clinicaltrials.gov/ct2/show/NCT04033003
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