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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.

SUBMITTER: Musange SF

PROVIDER: S-EPMC6792348 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Musange Sabine Furere SF Butrick Elizabeth E Lundeen Tiffany T Santos Nicole N Azman Firdaus Hana H Benitez Alejandra A Nzeyimana David D Kayiramirwa Murindahabi Nathalie N Nyiraneza Lauriane L Sayinzoga Felix F Ndahindwa Vedaste V Ngabo Fidele F Condo Jeanine J Walker Dylis D

Gates open research 20190927

<b>Background:</b> 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 o ...[more]

PMID: 31656954

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Project description:BackgroundResearch on group antenatal care in low- and middle-income contexts suggests high acceptability and preliminary implementation success.MethodsWe studied the effect of group antenatal care on gestational age at birth among women in Rwanda, hypothesizing that participation would increase mean gestational length. For this unblinded cluster randomized trial, 36 health centers were pair-matched and randomized; half continued individual antenatal care (control), half implemented group antenatal care (intervention). Women who initiated antenatal care between May 2017 and December 2018 were invited to participate, and included in analyses if they presented before 24 weeks gestation, attended at least two visits, and their birth outcome was obtained. We used a generalized estimating equations model for analysis.FindingsIn total, 4091 women in 18 control clusters and 4752 women in 18 intervention clusters were included in the analysis. On average, women attended three total antenatal care visits. Gestational length was equivalent in the intervention and control groups (39.3 weeks (SD 1.6) and 39.3 weeks (SD 1.5)). There were no significant differences between groups in secondary outcomes except that more women in control sites attended postnatal care visits (40.1% versus 29.7%, p = 0.003) and more women in intervention sites attended at least three total antenatal care visits (80.7% versus 71.7%, p = 0.003). No harms were observed.InterpretationGroup antenatal care did not result in a difference in gestational length between groups. This may be due to the low intervention dose. We suggest studies of both the effectiveness and costs of higher doses of group antenatal care among women at higher risk of preterm birth. We observed threats to group care due to facility staff shortages; we recommend studies in which antenatal care providers are exclusively allocated to group antenatal care during visits.Trial registrationClinicalTrials.gov NCT03154177.

Project description:BackgroundAs utilization of individual antenatal care (I-ANC) has increased throughout sub-Saharan Africa, questions have arisen about whether individual versus group-based care might yield better outcomes. We implemented a trial of group-based antenatal care (G-ANC) to determine its impact on birth preparedness and complication readiness (BPCR) among pregnant women in Ghana.MethodsWe conducted a cluster randomized controlled trial comparing G-ANC to routine antenatal care in 14 health facilities in the Eastern Region of Ghana. We recruited women in their first trimester to participate in eight two-hour interactive group sessions throughout their pregnancies. Meetings were facilitated by midwives trained in G-ANC methods, and clinical assessments were conducted in addition to group discussions and activities. Data were collected at five timepoints, and results are presented comparing baseline (T0) to 34 weeks' gestation to 3 weeks post-delivery (T1) for danger sign recognition, an 11-point additive scale of BPCR, as well as individual items comprising the scale.Results1285 participants completed T0 and T1 assessments (N = 668 I-ANC, N = 617, G-ANC). At T1, G-ANC participants were able to identify significantly more pregnancy danger signs than I-ANC participants (mean increase from 1.8 to 3.4 in G-ANC vs. 1.7 to 2.2 in I-ANC, p < 0.0001). Overall BPCR scores were significantly greater in the G-ANC group than the I-ANC group. The elements of BPCR that showed the greatest increases included arranging for emergency transport (I-ANC increased from 1.5 to 11.5% vs. G-ANC increasing from 2 to 41% (p < 0.0001)) and saving money for transportation (19-32% in the I-ANC group vs. 19-73% in the G-ANC group (p < 0.0001)). Identifying someone to accompany the woman to the facility rose from 1 to 3% in the I-ANC group vs. 2-20% in the G-ANC group (p < 0.001).ConclusionsG-ANC significantly increased BPCR among women in rural Eastern Region of Ghana when compared to routine antenatal care. Given the success of this intervention, future efforts that prioritize the implementation of G-ANC are warranted.Trial registrationClinicalTrials.gov Identifier: NCT04033003 (25/07/2019).Protocol availableProtocol Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9508671/ .

Project description:BackgroundAntenatal care is one of the key preventive health services used around the world. In most Western countries, antenatal care traditionally involves a schedule of one-to-one visits with a care provider. A different way of providing antenatal care involves use of a group model.Objectives1. To compare the effects of group antenatal care versus conventional antenatal care on psychosocial, physiological, labour and birth outcomes for women and their babies.2. To compare the effects of group antenatal care versus conventional antenatal care on care provider satisfaction.Search methodsWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2014), contacted experts in the field and reviewed the reference lists of retrieved studies.Selection criteriaAll identified published, unpublished and ongoing randomised and quasi-randomised controlled trials comparing group antenatal care with conventional antenatal care were included. Cluster-randomised trials were eligible, and one has been included. Cross-over trials were not eligible.Data collection and analysisTwo review authors independently assessed trials for inclusion and risk of bias and extracted data; all review authors checked data for accuracy.Main resultsWe included four studies (2350 women). The overall risk of bias for the included studies was assessed as acceptable in two studies and good in two studies. No statistically significant differences were observed between women who received group antenatal care and those given standard individual antenatal care for the primary outcome of preterm birth (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.57 to 1.00; three trials; N = 1888). The proportion of low-birthweight (less than 2500 g) babies was similar between groups (RR 0.92, 95% CI 0.68 to 1.23; three trials; N = 1935). No group differences were noted for the primary outcomes small-for-gestational age (RR 0.92, 95% CI 0.68 to 1.24; two trials; N = 1473) and perinatal mortality (RR 0.63, 95% CI 0.32 to 1.25; three trials; N = 1943).Satisfaction was rated as high among women who were allocated to group antenatal care, but this outcome was measured in only one trial. In this trial, mean satisfaction with care in the group given antenatal care was almost five times greater than that reported by those allocated to standard care (mean difference 4.90, 95% CI 3.10 to 6.70; one study; N = 993). No differences in neonatal intensive care admission, initiation of breastfeeding or spontaneous vaginal birth were observed between groups. Several outcomes related to stress and depression were reported in one trial. No differences between groups were observed for any of these outcomes.No data were available on the effects of group antenatal care on care provider satisfaction.We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to assess evidence for seven prespecified outcomes; results ranged from low quality (perinatal mortality) to moderate quality (preterm birth, low birthweight, neonatal intensive care unit admission, breastfeeding initiation) to high quality (satisfaction with antenatal care, spontaneous vaginal birth).Authors' conclusionsAvailable evidence suggests that group antenatal care is positively viewed by women and is associated with no adverse outcomes for them or for their babies. No differences in the rate of preterm birth were reported when women received group antenatal care. This review is limited because of the small numbers of studies and women, and because one study contributed 42% of the women. Most of the analyses are based on a single study. Additional research is required to determine whether group antenatal care is associated with significant benefit in terms of preterm birth or birthweight.

Project description:BackgroundThe Preterm Birth Initiative-Rwanda is conducting a 36-cluster randomized controlled trial of group antenatal and postnatal care. In the context of this trial, we collected qualitative data before and after implementation. The purpose was two-fold. First, to inform the design of the group care program before implementation and second, to document women's experiences of group care at the mid-point of the trial to make ongoing programmatic adjustments and improvements.MethodsWe completed 8 focus group discussions among women of reproductive age before group care implementation and 6 focus group discussions among women who participated in group antenatal care and/or postnatal care at 18 health centers that introduced the model, approximately 9 months after implementation.ResultsBefore implementation, focus group participants reported both enthusiasm for the potential for support and insight from a group of peers and concern about the risk of sharing private information with peers who may judge, mock, or gossip. After implementation, group care participants reported benefits including increased knowledge, peer support, and more satisfying relationships with providers. When asked about barriers to group care participation, none of them cited concern about privacy but instead cited lack of financial resources, lack of cooperation from a male partner, and long distances to the health center. Finally, women stated that the group care experience would be improved if all participants and providers arrived on time and remained focused on the group care visit throughout.DiscussionThese results are consistent with other published reports of women's perceptions of group antenatal care, especially increased pregnancy- and parenting-related knowledge, peer support, and improved relationships with health care providers. Some results were unexpected, especially the consequences of staff allocation patterns that resulted in providers arriving late for group visits or having to leave during group visits to attend to other facility services, which diminished women's experiences of care.ConclusionGroup antenatal and postnatal care provide compelling benefits to women and families. If the model requires the addition of human resources at the health center, intensive reminder communications, and large-scale community outreach to benefit the largest number of pregnant and postnatal mothers, those additional resources required must be factored into any future decision to scale a group care model.Trial registrationThis trial is registered at clinicaltrials.gov as NCT03154177 .

Project description:ObjectivesComparing language-supported group antenatal care (gANC) and standard antenatal care (sANC) for Somali-born women in Sweden, measuring overall ratings of care and emotional well-being, and testing the feasibility of the outcome measures.DesignA quasi-experimental trial with one intervention and one historical control group, nested in an intervention development and feasibility study.SettingMidwifery-led antenatal care clinic in a mid-sized Swedish town.ParticipantsPregnant Somali-born women (<25 gestational weeks); 64 women in gANC and 81 in sANC.InterventionLanguage-supported gANC (2017-2019). Participants were offered seven 60-minute group sessions with other Somali-born women led by one to two midwives, in addition to 15-30 min individual appointments with their designated midwife.OutcomesPrimary outcomes were women's overall ratings of antenatal care and emotional well-being (Edinburgh Postnatal Depression Scale (EPDS)) in gestational week ≥35 and 2 months post partum. Secondary outcomes were specific care experiences, information received, social support, knowledge of pregnancy danger signs and obstetric outcomes.ResultsRecruitment and retention of participants were challenging. Of eligible women, 39.3% (n=106) declined to participate. No relevant differences regarding overall ratings of antenatal care between the groups were detected (late pregnancy OR 1.42, 95% CI 0.50 to 4.16 and 6-8 weeks post partum OR 2.71, 95% CI 0.88 to 9.41). The reduction in mean EPDS score was greater in the intervention group when adjusting for differences at baseline (mean difference -1.89; 95% CI -3.73 to -0.07). Women in gANC were happier with received pregnancy and birth information, for example, caesarean section where 94.9% (n=37) believed the information was sufficient compared with 17.5% (n=7) in standard care (p<0.001) in late pregnancy.ConclusionsThis evaluation suggests potential for language-supported gANC to improve knowledge acquisition among pregnant Somali-born women with residence in Sweden ˂10 years. An adequately powered randomised trial is needed to evaluate the effectiveness of the intervention.Trial registration numberClinicalTrials.gov Registry (NCT03879200).

Project description:BACKGROUND:Low quality and frequency of antenatal care (ANC) are associated with lower uptake of facility-based deliveries-a key intervention to reduce maternal and neonatal mortality. We implemented group ANC (G-ANC), an alternative service delivery model, in Kenya and Nigeria, to assess its impact on quality and attendance at ANC and uptake of facility-based delivery. METHODS:From October 2016‒January 2018, we conducted a facility-based, pragmatic, cluster-randomized controlled trial with 20 clusters per country. We recruited women <24 weeks gestation during their first ANC visit and enrolled women at intervention facilities who agreed to attend G-ANC in lieu of routine individual ANC. The G-ANC model consisted of five monthly 2-hour meetings with clinical assessments alongside structured gestationally specific group discussions and activities. Quality of care was defined as receipt of eight specific ANC interventions. Data were obtained through facility records and self-report during a home-based postpartum survey. Analysis was by intention to treat. FINDINGS:All women who completed follow up are included in the analysis (Nigeria: 1018/1075 enrolled women [94.7%], Kenya: 826/1013 [81.5%]). In Nigeria women in the intervention arm were more likely to have a facility-based delivery compared to those in the control arm (Nigeria: 76.7% [391/510] versus 54.1% [275/508]; aOR 2.30, CI 1.51-3.49). In both countries women in the intervention arm were more likely than those in the control arm to receive quality ANC (Nigeria: aOR 5.8, CI 1.98-17.21, p<0.001; Kenya: aOR 5.08, CI 2.31-11.16, p<0.001) and to attend at least four ANC visits (Nigeria: aOR 13.30, CI 7.69-22.99, p<0.001; Kenya: aOR 7.12, CI 3.91-12.97, p<0.001). CONCLUSIONS:G-ANC was associated with higher facility-based delivery rates in Nigeria, where those rates associated with individual ANC were low. In both Kenya and Nigeria it was associated with a higher proportion of women receiving quality ANC and higher frequency of ANC visits.

Dataset Information

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

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

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