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.

Keywords: Antenatal care; Centering Pregnancy; Gestational age; Group based antenatal care; Group prenatal care; Postnatal care; Group care; Pregnancy; Preterm birth; Sub-Saharan Africa.

Conflict of interest statement

No competing interests were disclosed.

Copyright: © 2019 Musange SF et al.

Figures

Figure 1.. Facility-level randomization of 36 health centers included in a cluster randomized controlled trial of group antenatal care and postnatal care in Rwanda.

Arm 1 delivers standard antenatal and postnatal care only and is the pure control. Arm 2 delivers standard antenatal and postnatal care, with the addition of early pregnancy testing in the community and obstetric ultrasound performed by primary antenatal care providers. Arm 3 delivers group antenatal and postnatal care, and Arm 4 delivers group antenatal and postnatal care with the addition of early pregnancy testing and ultrasound. In health centers randomized to group care (Arms 3 and 4), this model will follow the opt-out standard of care for facility-based antenatal and postnatal care. This design makes it possible to analyze differences between group care and standard care and also to assess if those effects are mediated by early pregnancy testing in the community or the availability of ultrasound (especially for early gestational age assessment) at the health center. HC, health center; US, ultrasound; PT, pregnancy testing.

Figure 2.. CONSORT flow diagram .

ANC, antenatal care; US, ultrasound; UPT, urine pregnancy test; GA, gestational age.