An interventional study of Group ANC/PNC and Ultrasound+Pregnancy Testing in Pregnancy Complications, Preterm Birth and Preterm Labor, sponsored by University of California, San Francisco. Completed at 2 sites in Rwanda. Open to female participants aged 13 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-25.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
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:
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:
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:
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.
445 studies on the registry are indexed under Pregnancy Complications; 118 are open to participants now.
This study's enrollment of 26,381 is above the median of 148 across 224 interventional studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individual inclusion Criteria:
Women receiving ANC and PNC care
Providers • Currently provide antenatal or postnatal care
Individual exclusion Criteria:
Women receiving ANC and PNC care
Providers
Site-level exclusion criteria:
Site-level inclusion criteria:
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
Standard care offered following national guidelines of ANC and PNC.
Standard care in combination with early pregnancy testing and ultrasound.
Procedure: Ultrasound+Pregnancy Testing
Health facilities randomized to provide group ANC/PNC.
Behavioral: Group ANC/PNC
Group ANC and PNC care, in combination with early pregnancy testing and ultrasound.
Behavioral: Group ANC/PNC · Procedure: Ultrasound+Pregnancy Testing
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.
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.
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.
Time frame: within the first 3 days after delivery
Preterm birth rate
Proportion of preterm deliveries among mothers enrolled in ANC
Time frame: At delivery
Preterm 28-day and 42-day mortality rate
28-day and 42-day mortality rate among preterm infants whose mother enrolled in ANC
Time frame: 28 days and 42 days post delivery
Women who adhered to four ANC visits
Proportion of women who adhered to four ANC visits among all mothers who have received at least one ANC visit at facility.
Time frame: From the day of first ANC visit at the health center until the day of delivery
Adherence to 6 week postnatal visit
Proportion of women who adhered to the 6-week PNC visit at the health center among those who attended at least 2 ANC at the facility.
Time frame: 42 days post delivery
1st ANC visit during the first trimester
Proportion of women with 1st ANC visit during the first trimester among those who have at least one ANC visit.
Time frame: up to 14 weeks gestation
High-risk Women
Proportion of women identified during ANC as being high-risk
Time frame: From the day of first ANC visit at the health center until the day of delivery
C-section deliveries
Proportion of pregnancies resulting in C-section deliveries among those enrolled in ANC at facility.
Time frame: At Delivery
Newborns with neonatal morbidities, specifically, jaundice, rapid breathing, fever, pneumonia, hypothermia, and/or cord infection
Proportion of newborns with neonatal morbidities, specifically, jaundice, rapid breathing, fever, pneumonia, hypothermia, and/or cord infection, among all those whose mother received ANC at facility, and among all those who received PNC at facility.
Time frame: 28 days post delivery
Cost-effectiveness
Costs of ANC delivery and program costs will be collected prospectively, and costs associated with each adverse outcome that may be potentially averted will be calculated. Effectiveness measures will be: number of deliveries conducted by skilled health workers; total number of ANC visits, first ANC visit before 16 weeks and 4 standard ANC visits completed; and number of preterm births prevented.
Time frame: 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
Qualitative work (in-depth interviews and focus group discussions) with women and providers to inform any fine tuning to the model will be conducted at 9 and 18 months after implementation.
Time frame: up to 18 months
Plan to share: Undecided — Data from the study will be shared, but the extent to which individual participant data can be shared is yet to be determined. This will be done to the extent possible, conforming to any partner requirements or Rwanda IRB requirements.
Ran from May 2017 to primary completion in May 2019, 24 months.
Of 133 non-industry interventional studies with no phase under Pregnancy Complications, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 24 months is below that.
Counting every sponsor, half of 133 studies reached it within 29 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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