Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial

Abstract

Background: Group antenatal care has demonstrated promise as a service delivery model that may result in improved outcomes compared to standard antenatal care in socio-demographic populations at disparately high risk for poor perinatal outcomes. Intrigued by results from the United States showing lower preterm birth rates among high-risk women who participate in group antenatal care, partners working together as the Preterm Birth Initiative - Rwanda designed a trial to assess the impact of group antenatal care on gestational age at birth. Methods: This study is a pair-matched cluster randomized controlled trial with four arms. Pairs randomized to group or standard care were further matched with other pairs into quadruples, within which one pair was assigned to implement basic obstetric ultrasound at the health center and early pregnancy testing at the community. At facilities randomized to group care, this will follow the opt-out model of service delivery and individual visits will always be available for those who need or prefer them. The primary outcome of interest is mean gestational age at birth among women who presented for antenatal care before 24 completed weeks of pregnancy and attended more than one antenatal care visit. Secondary outcomes of interest include attendance at antenatal and postnatal care, preterm birth rates, satisfaction of mothers and providers, and feasibility. A convenience sample of women will be recruited to participate in a longitudinal survey in which they will report such indicators as self-reported health-related behaviors and depressive symptoms. Providers will be surveyed about satisfaction and stress. Discussion: This is the largest cluster randomized controlled trial of group antenatal and postnatal care ever conducted, and the first in a low- or middle-income country to examine the effect of this model on gestational age at birth. Trial registration: This study is registered on ClinicalTrials.gov as NCT03154177 May 16, 2017.

Assessing the impact of group antenatal care on gestational length in Rwanda: A cluster-randomized trial

“…This study included one primary (group antenatal care) and two secondary (basic obstetric ultrasound and urine pregnancy tests in the community) interventions. These interventions are described below, and more details are available in a separate publication [ 17 ].…”

“…During the second hour of the session, the provider and community health worker co-facilitated a discussion of health-related topics that aligned with the stage of pregnancy and the health issues of highest importance at that time. The full list of visit timing and topics at each visit are described elsewhere [ 17 ]. Providers and community health workers elicited concerns and questions from women and encouraged group care participants to share knowledge and support with one another.…”

An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi

“…However, the WHO was cautious, because premature adoption of a new model can have serious negative consequences, as exemplified by the reversal of the 4visit model [39]. A growing body of literature shows that group antenatal care is feasible and acceptable in many low and middle-income countries across the globe [40][41][42][43][44][45][46][47][48][49][50]. Additional work is underway in Mali, China, Ethiopia, Surinam, and elsewhere [51].…”

“…Additional work is underway in Mali, China, Ethiopia, Surinam, and elsewhere [51]. Most of these studies do not yet have results, but 3 studies in Africa have noted positive outcomes [43,52,53]. A large cluster-randomized trial in Nigeria and Kenya found greater antenatal care attendance in both countries and more birth planning for a facility-based birth in Nigeria [52,53].…”

“…Additionally, many studies lack adequate power to test for effects on birth outcomes (e.g., prematurity and/or low birthweight). One large cluster randomized trial currently underway in Rwanda is adequately powered to examine preterm birth, but the model deviates on three key practices of the CenteringPregnancy model (e.g., lack of continuity of co-facilitators and group members (women can drop into other groups) and group size can be larger than 12) [42,43]. Our study, taking place in Malawi, fills both the power and fidelity gaps while implementing group antenatal care in the context of a midwife shortage and high rates of prematurity and HIV infection [13,56,57].…”