NCT03154177: PTBi Rwanda

Group Antenatal/Postnatal Care in Rwanda

Completed NA Last updated 25 June 2019

What this trial tests

NA trial testing Group ANC/PNC in Pregnancy Complications in 26,381 participants. Completed in 31 May 2019.

Timeline

15 May 2017

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	26,381
Start date	15 May 2017
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	2 locations across Rwanda

Drugs / interventions tested

• Group ANC/PNC
• Ultrasound+Pregnancy Testing

Conditions studied

• Pregnancy Complications — all drugs for Pregnancy Complications →
• Preterm Birth — all drugs for Preterm Birth →
• Preterm Labor — all drugs for Preterm Labor →
• Stillbirth — all drugs for Stillbirth →

Sponsor

University of California, San Francisco

Who can join

Adults 13 to 64, female only, with Pregnancy Complications or Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The focus of this work is to improve antenatal care (ANC) and postnatal care (PNC) at the health center level in five districts in Rwanda (Bugesera, Burera, Nyamasheke, Nyarugenge, and Rubavu). 36 health centers in these districts are included in this cluster randomized control trial (RCT) of group ANC and PNC care to measure this alternative model's effects on gestational age at birth, survival of preterm and low birth weight infants at 42 days of life, and ANC and PNC coverage. To improve antenatal assessment of gestational age, nurses will be trained in obstetric ultrasound at 18 health centers. These facilities will also incorporate pregnancy testing with urine dipstick to be performed by community health workers in charge of maternal health to facilitate early entry into ANC. This trial will test the hypothesis that women who participate in this alternative model of group ANC will experience increased gestational age at birth, as compared to women who receive standard focused ANC. This study is a collaboration with the University of Rwanda, the Rwandan Ministry of Health (MOH), the Rwanda Biomedical Center, and UCSF.

The group care model used in this study is Rwanda-specific model developed by a Rwandan technical working group. The model includes an individual clinical visit for the first antenatal visit, followed by three group visits spaced about 8 weeks apart throughout pregnancy and a postnatal group visit at approximately 6 weeks after birth. Women will be grouped into stable groups of approximately 8-12 women with similar due dates. A community health worker (CHW) and a health center nurse will work together as co-facilitators to lead each of the groups. Each group visit includes clinical assessment, education, and treatments as appropriate for the women who attend. The model is founded on facilitative leadership of the groups, in which the co-facilitators allow women's experiences and interests to drive the content and women are encouraged to help one another cope with obstacles to optimal health. Facilitators will be supported by master trainers who will visit health centers to observe group sessions and offer supportive feedback.

Data collected in this trial will include measures of the satisfaction of both women and providers with the group care, content of care differences between standard and group care, and perinatal outcomes such as gestational age at delivery and 42-day preterm and low birth weight infant survival.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of a Facilitated Group Process to Design and Implement a Group Antenatal and Postnatal Care Program in Rwanda.
   Sayinzoga F, Lundeen T, Gakwerere M, Manzi E, et al · · 2018 · cited 26× · PMID 30251304 · DOI 10.1111/jmwh.12871
2. Before and after implementation of group antenatal care in Rwanda: a qualitative study of women's experiences.
   Musabyimana A, Lundeen T, Butrick E, Sayinzoga F, et al · · 2019 · cited 25× · PMID 31248425 · DOI 10.1186/s12978-019-0750-5
3. 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 SF, Butrick E, Lundeen T, Santos N, et al · · 2019 · cited 21× · PMID 31656954 · DOI 10.12688/gatesopenres.13053.1
4. Nurses' and midwives' experiences of providing group antenatal and postnatal care at 18 health centers in Rwanda: A mixed methods study.
   Lundeen T, Musange S, Azman H, Nzeyimana D, et al · · 2019 · cited 18× · PMID 31295335 · DOI 10.1371/journal.pone.0219471
5. Person-centered antenatal care and associated factors in Rwanda: a secondary analysis of program data.
   Miller P, Afulani PA, Musange S, Sayingoza F, et al · · 2021 · cited 12× · PMID 33838658 · DOI 10.1186/s12884-021-03747-z
6. Assessing the impact of group antenatal care on gestational length in Rwanda: A cluster-randomized trial.
   Sayinzoga F, Lundeen T, Musange SF, Butrick E, et al · · 2021 · cited 12× · PMID 33529256 · DOI 10.1371/journal.pone.0246442
7. Towards stronger antenatal care: Understanding predictors of late presentation to antenatal services and implications for obstetric risk management in Rwanda.
   Schmidt CN, Butrick E, Musange S, Mulindahabi N, et al · · 2021 · cited 11× · PMID 34432829 · DOI 10.1371/journal.pone.0256415
8. Predictors of postpartum family planning in Rwanda: the influence of male involvement and healthcare experience.
   Williams P, Santos N, Azman-Firdaus H, Musange S, et al · · 2021 · cited 11× · PMID 33740975 · DOI 10.1186/s12905-021-01253-0