Group Antenatal/Postnatal Care in Rwanda

NCT03154177 | Completed

• 1 other identifier: A123218-Rw (UCSF RAS #)
• Study Type: interventional
• Target: 26,381
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Gestational Age

  Average gestational age at delivery among women who enroll in ANC before 24 weeks of gestation and had at least 2 ANC visits at that facility.

  within the first 3 days after delivery

Secondary Outcomes (8)

• Preterm birth rate

  At delivery

• Preterm 28-day and 42-day mortality rate

  28 days and 42 days post delivery

• Women who adhered to four ANC visits

  From the day of first ANC visit at the health center until the day of delivery

• Adherence to 6 week postnatal visit

  42 days post delivery

• 1st ANC visit during the first trimester

  up to 14 weeks gestation

Other Outcomes (2)

• Cost-effectiveness

  Costs will be measured prospectively from baseline through the end of the intervention once sample size is achieve--approximately 18 months from baseline.

• Qualitative assessment of group care feasibility and acceptability to women and providers

  up to 18 months

Study Arms (4)

Standard ANC and PNC care only

NO INTERVENTION

Standard care offered following national guidelines of ANC and PNC.

Standard Care + Ultrasound+Pregnancy Testing

OTHER

Standard care in combination with early pregnancy testing and ultrasound.

Procedure: Ultrasound+Pregnancy Testing

Group ANC and PNC only

EXPERIMENTAL

Health facilities randomized to provide group ANC/PNC.

Behavioral: Group ANC/PNC

Group Care + Ultrasound+Pregnancy Testing

EXPERIMENTAL

Group ANC and PNC care, in combination with early pregnancy testing and ultrasound.

Behavioral: Group ANC/PNC; Procedure: Ultrasound+Pregnancy Testing

Interventions

Group ANC/PNC BEHAVIORAL

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.

Group ANC and PNC only; Group Care + Ultrasound+Pregnancy Testing

Ultrasound+Pregnancy Testing PROCEDURE

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.

Group Care + Ultrasound+Pregnancy Testing; Standard Care + Ultrasound+Pregnancy Testing

Eligibility Criteria

• Age: 13 Years - 64 Years
• Gender Eligibility Details: Only female participants are being studied (assuming mom's will be source of GA measurement at delivery).
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women receiving ANC and PNC care
• all women who enroll in ANC -including pregnant adolescents
• primary data analysis will be restricted to those women in the intervention and control facilities who present for ANC 1 before 24 weeks gestation and have attended more than 1 ANC visit at the health facility.
• Providers • Currently provide antenatal or postnatal care

You may not qualify if:

• Women receiving ANC and PNC care
• women who present for ANC 1 after 24 weeks gestation
• women who do not attend more than 1 ANC at the health facility will be excluded from the primary analysis
• Providers
• Providers that do not provide antenatal or postnatal care
• sites that have less than 2 ANC providers.
• Study sites that have at least 2 ANC providers were included in the final selection of 36 sites. The following are study sites by district:
• Nyamasheke District Nyamasheke Kibingo Mugera Mwezi Karengera Kibogora Gisakura Yove
• Nyarugenge District Cor-unum Biryogo Rugarama Kabusunzu
• Rubavu District Murara Nyakiriba Busasamana Karambo Gisenyi Kigufi Mudende
• Bugesera District Ruhuha Gakurazo Gashora Ngeruka Kamabuye Nyamata Ntarama Juru Mayange Nzangwa Nyarugenge
• Burera District Cyanika Kirambo Ndongozi Gitare Gahunga Mucaca

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Rwanda: collaborator
• Rwanda Biomedical Centre: collaborator
• Ministry of Health, Rwanda: collaborator

Study Sites (2)

Rwanda Biomedical Center

Kigali, Rwanda

Location

University of Rwanda

Kigali, Rwanda

Location

Related Publications (11)

• Lincetto O, Mothebesoane-Anoh S, Gomez P, Munjanja S. Antenatal care. Chapter 2. Opportunities for Africa's Newborns.

  BACKGROUND

• Bhutta ZA, Das JK, Bahl R, Lawn JE, Salam RA, Paul VK, Sankar MJ, Blencowe H, Rizvi A, Chou VB, Walker N; Lancet Newborn Interventions Review Group; Lancet Every Newborn Study Group. Can available interventions end preventable deaths in mothers, newborn babies, and stillbirths, and at what cost? Lancet. 2014 Jul 26;384(9940):347-70. doi: 10.1016/S0140-6736(14)60792-3. Epub 2014 May 19.

  PMID: 24853604 BACKGROUND

• National Institute of Statistics of Rwanda. (2015). Demographic and Health Survey 2014-2015: Key Findings.

  BACKGROUND

• Ickovics JR, Kershaw TS, Westdahl C, Magriples U, Massey Z, Reynolds H, Rising SS. Group prenatal care and perinatal outcomes: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):330-9. doi: 10.1097/01.AOG.0000275284.24298.23.

  PMID: 17666608 BACKGROUND

• Catling CJ, Medley N, Foureur M, Ryan C, Leap N, Teate A, Homer CS. Group versus conventional antenatal care for women. Cochrane Database Syst Rev. 2015 Feb 4;2015(2):CD007622. doi: 10.1002/14651858.CD007622.pub3.

  PMID: 25922865 BACKGROUND

• Maternal Health Task Force, Harvard School of Public Health, et al. Group Care. Innovative Methods 2014.

  BACKGROUND

• Prost A, Colbourn T, Seward N, Azad K, Coomarasamy A, Copas A, Houweling TA, Fottrell E, Kuddus A, Lewycka S, MacArthur C, Manandhar D, Morrison J, Mwansambo C, Nair N, Nambiar B, Osrin D, Pagel C, Phiri T, Pulkki-Brannstrom AM, Rosato M, Skordis-Worrall J, Saville N, More NS, Shrestha B, Tripathy P, Wilson A, Costello A. Women's groups practising participatory learning and action to improve maternal and newborn health in low-resource settings: a systematic review and meta-analysis. Lancet. 2013 May 18;381(9879):1736-46. doi: 10.1016/S0140-6736(13)60685-6.

  PMID: 23683640 BACKGROUND

• Sayinzoga F, Lundeen T, Musange SF, Butrick E, Nzeyimana D, Murindahabi N, Azman-Firdaus H, Sloan NL, Benitez A, Phillips B, Ghosh R, Walker D. Assessing the impact of group antenatal care on gestational length in Rwanda: A cluster-randomized trial. PLoS One. 2021 Feb 2;16(2):e0246442. doi: 10.1371/journal.pone.0246442. eCollection 2021.

  PMID: 33529256 DERIVED

• Musange SF, Butrick E, Lundeen T, Santos N, Azman Firdaus H, Benitez A, Nzeyimana D, Kayiramirwa Murindahabi N, Nyiraneza L, Sayinzoga F, Ndahindwa V, Ngabo F, Condo J, Walker D. Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial. Gates Open Res. 2019 Sep 27;3:1548. doi: 10.12688/gatesopenres.13053.1. eCollection 2019.

  PMID: 31656954 DERIVED

• Lundeen T, Musange S, Azman H, Nzeyimana D, Murindahabi N, Butrick E, Walker D. Nurses' and midwives' experiences of providing group antenatal and postnatal care at 18 health centers in Rwanda: A mixed methods study. PLoS One. 2019 Jul 11;14(7):e0219471. doi: 10.1371/journal.pone.0219471. eCollection 2019.

  PMID: 31295335 DERIVED

• Musabyimana A, Lundeen T, Butrick E, Sayinzoga F, Rwabufigiri BN, Walker D, Musange SF. Before and after implementation of group antenatal care in Rwanda: a qualitative study of women's experiences. Reprod Health. 2019 Jun 27;16(1):90. doi: 10.1186/s12978-019-0750-5.

  PMID: 31248425 DERIVED

MeSH Terms

Conditions

Pregnancy Complications; Premature Birth; Obstetric Labor, Premature; Stillbirth

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilys Walker, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Sabine F Musange, MD, MSc

  University of Rwanda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 16, 2017
• Study Start: May 15, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

RW (2)