Group Antenatal/Postnatal Care in Rwanda
NCT03154177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26381
Last updated 2019-06-25
Summary
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.
Conditions
- Pregnancy Complications
- Preterm Birth
- Preterm Labor
- Stillbirth
- Low Birth Weight
- Neonatal Mortality
Interventions
- BEHAVIORAL
-
Group ANC/PNC
The primary intervention is group antenatal and postnatal care wherein women receive their care in a group with other women with similar due dates. After an initial individual visit all care is given in groups although the majority of the time is dedicated to facilitated discussion and women can come for additional acute care if needed. Group antenatal care will be three group visits between 20 and 40 weeks gestation and group postnatal care will be one group visit and approximately 6 weeks post delivery.
- PROCEDURE
-
Ultrasound+Pregnancy Testing
Half of all study sites will receive early pregnancy testing, conducted by community health workers at community level and ultrasound for gestational age dating and early screening at the health center. The primary analysis will not assess the effectiveness of this intervention.
Sponsors & Collaborators
-
University of Rwanda
collaborator OTHER -
Rwanda Biomedical Centre
collaborator OTHER -
Ministry of Health, Rwanda
collaborator OTHER_GOV -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Dilys Walker, MD · University of California, San Francisco
-
Sabine F Musange, MD, MSc · University of Rwanda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 13 Years
- Max Age
- 64 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-05-15
- Primary Completion
- 2019-05-31
- Completion
- 2019-05-31
Countries
- Rwanda
Study Locations
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