Clinical trial NCT03154177: Group Antenatal/Postnatal Care in Rwanda
Official title: Group Antenatal/Postnatal Care in Rwanda: a Cluster Randomized Control Trial (RCT) to Measure Its Effectiveness on Increasing Gestational Age, Mortality Among Preterm and Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Preterm Birth
Preterm Labor
Stillbirth
Low Birth Weight
Neonatal Mortality
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Rwanda
name: Rwanda Biomedical Centre
name: Ministry of Health, Rwanda
First posted: 2017-05-16
Enrollment: 26381
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed description: This study aims to determine the effect of a group care model, which incorporates both group care antenatal (ANC) and postnatal care (PNC), on the following:

1. Gestational age (GA) at birth;
2. Adherence to the recommended four ANC and one facility-based PNC visits; and
3. Mortality at 42 days among preterm and low birth weight infants.

In this cluster RCT at the health center level, facilities will be pair-matched based on factors affecting GA at delivery such as monthly ANC enrollment, quality of ANC and PNC delivery, potential lost-to-follow-up (LTFU) rate, and additional criteria pertaining to facility capacity. Within each pair, a facility will be randomly chosen to implement the intervention, group ANC and PNC, while the control facility will continue to provide standard ANC and PNC. Pairs will then be further matched with other pairs into quadruples (to the extent possible), within which one pair will be assigned to additionally implement ultrasound at the health center level and early pregnancy testing at the community level. Overall, each facility will have one of the following assignments:

* Arm 1: Standard ANC and PNC care only
* Arm 2: Standard ANC and PNC care, with the addition of early pregnancy testing and ultrasound
* Arm 3: Group ANC and PNC only
* Arm 4: Group ANC and PNC care, with the addition of early pregnancy testing and ultrasound

This design will allow a primary analysis on the difference between group care and standard care and will also make it possible to assess the effect of early pregnancy testing in the community and obstetric ultrasound at the health center on early entry into ANC and number of visits attended.

The Rwanda group ANC/PNC model was developed by a Technical Working Group of representatives from maternal-child health stakeholders in Rwanda. Key characteristics:

1. Women sit in a circle in a group space where confidentiality and mutual respect are prioritized. Key messages consistent with Rwanda's ANC/PNC packages are delivered through facilitated discussion; women speak more than the facilitators.
2. Women and newborns receive the routine assessments, screening, and treatments described in the Rwanda guidelines, as well as treatments indicated for special conditions. Health assessments are conducted at the start of the visit, and women participate as much as possible in their own self-assessments. Individual consultations with facilitators are conducted in a semi-private area.
3. Two co-facilitators lead each group visit (one midwife/nurse and one CHW). Co-facilitators "debrief" after every group visit in a continuous learning and quality improvement process. The group care co-facilitators are trained and supported by 6 Rwandan Master Trainers.
4. Women can return to the health facility at any time for evaluation of danger signs or other concerns. Referrals to the district hospital are done per current national guidelines.

Both control and intervention sites, as well as district hospitals that may receive referrals from our study sites, will receive the initial intervention of data strengthening and training around data use activities so as to improve the quality of data being collected and strengthen outcome measurement within all facilities involved in the study

Additionally, in order to evaluate other secondary outcomes, data will also be collected through: (1) questionnaires administered to a random sample of ANC and PNC participants and all providers at baseline and different time points throughout the study; (2) observations and debriefs of group care sessions; (3) qualitative research around acceptability of the group model from participants and providers; (4) cost-effectiveness analysis of the group care model.

Eligibility criteria: Individual inclusion Criteria:

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

Individual exclusion Criteria:

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

Site-level exclusion criteria:

• sites that have less than 2 ANC providers.

Site-level inclusion criteria:

• 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

Primary outcomes:
measure: Gestational Age
timeFrame: within the first 3 days after delivery
Secondary outcomes:
measure: Preterm birth rate
timeFrame: At delivery
measure: Preterm 28-day and 42-day mortality rate
timeFrame: 28 days and 42 days post delivery
measure: Women who adhered to four ANC visits
timeFrame: From the day of first ANC visit at the health center until the day of delivery
measure: Adherence to 6 week postnatal visit
timeFrame: 42 days post delivery
measure: 1st ANC visit during the first trimester
timeFrame: up to 14 weeks gestation
measure: High-risk Women
timeFrame: From the day of first ANC visit at the health center until the day of delivery
measure: C-section deliveries
timeFrame: At Delivery
measure: Newborns with neonatal morbidities, specifically, jaundice, rapid breathing, fever, pneumonia, hypothermia, and/or cord infection
timeFrame: 28 days post delivery
Other outcomes:
measure: Cost-effectiveness
timeFrame: Costs will be measured prospectively from baseline through the end of the intervention once sample size is achieve--approximately 18 months from baseline.
measure: Qualitative assessment of group care feasibility and acceptability to women and providers
timeFrame: up to 18 months
Locations:
city: Kigali
country: Rwanda
facility: Rwanda Biomedical Center
city: Kigali
country: Rwanda
facility: University of Rwanda
Study officials:
affiliation: University of California, San Francisco
name: Dilys Walker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rwanda
name: Sabine F Musange, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lincetto O, Mothebesoane-Anoh S, Gomez P, Munjanja S. Antenatal care. Chapter 2. Opportunities for Africa's Newborns.
citation: 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.
citation: National Institute of Statistics of Rwanda. (2015). Demographic and Health Survey 2014-2015: Key Findings.
citation: 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.
citation: 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.
citation: Maternal Health Task Force, Harvard School of Public Health, et al. Group Care. Innovative Methods 2014.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.