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Group Antenatal/Postnatal Care in Rwanda (PTBi Rwanda)

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ClinicalTrials.gov Identifier: NCT03154177
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
University of Rwanda
Rwanda Biomedical Center
Ministry of Health, Rwanda
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Pregnancy Complications Preterm Birth Preterm Labor Stillbirth Low Birth Weight Neonatal Mortality Behavioral: Group ANC/PNC Procedure: Ultrasound+Pregnancy Testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26381 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard ANC and PNC care only
Standard care offered following national guidelines of ANC and PNC.
Standard Care + Ultrasound+Pregnancy Testing
Standard care in combination with early pregnancy testing and ultrasound.
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.


Experimental: Group ANC and PNC only
Health facilities randomized to provide group ANC/PNC.
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.

Experimental: Group Care + Ultrasound+Pregnancy Testing
Group ANC and PNC care, in combination with early pregnancy testing and ultrasound.
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.





Primary Outcome Measures :
  1. Gestational Age [ Time Frame: within the first 3 days after delivery ]
    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.


Secondary Outcome Measures :
  1. Preterm birth rate [ Time Frame: At delivery ]
    Proportion of preterm deliveries among mothers enrolled in ANC

  2. Preterm 28-day and 42-day mortality rate [ Time Frame: 28 days and 42 days post delivery ]
    28-day and 42-day mortality rate among preterm infants whose mother enrolled in ANC

  3. Women who adhered to four ANC visits [ Time Frame: From the day of first ANC visit at the health center until the day of delivery ]
    Proportion of women who adhered to four ANC visits among all mothers who have received at least one ANC visit at facility.

  4. Adherence to 6 week postnatal visit [ Time Frame: 42 days post delivery ]
    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.

  5. 1st ANC visit during the first trimester [ Time Frame: up to 14 weeks gestation ]
    Proportion of women with 1st ANC visit during the first trimester among those who have at least one ANC visit.

  6. High-risk Women [ Time Frame: From the day of first ANC visit at the health center until the day of delivery ]
    Proportion of women identified during ANC as being high-risk

  7. C-section deliveries [ Time Frame: At Delivery ]
    Proportion of pregnancies resulting in C-section deliveries among those enrolled in ANC at facility.

  8. Newborns with neonatal morbidities, specifically, jaundice, rapid breathing, fever, pneumonia, hypothermia, and/or cord infection [ Time Frame: 28 days post delivery ]
    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.


Other Outcome Measures:
  1. Cost-effectiveness [ 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. ]
    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.

  2. Qualitative assessment of group care feasibility and acceptability to women and providers [ Time Frame: up to 18 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female participants are being studied (assuming mom's will be source of GA measurement at delivery).
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154177


Locations
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Rwanda
Rwanda Biomedical Center
Kigali, Rwanda
University of Rwanda
Kigali, Rwanda
Sponsors and Collaborators
University of California, San Francisco
University of Rwanda
Rwanda Biomedical Center
Ministry of Health, Rwanda
Investigators
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Principal Investigator: Dilys Walker, MD University of California, San Francisco
Principal Investigator: Sabine F Musange, MD, MSc University of Rwanda
Publications:
Lincetto O, Mothebesoane-Anoh S, Gomez P, Munjanja S. Antenatal care. Chapter 2. Opportunities for Africa's Newborns.
National Institute of Statistics of Rwanda. (2015). Demographic and Health Survey 2014-2015: Key Findings.
Ickovics, J., Kershaw, T., Westdahl, C., Magriples, U., Massey, Z., Reynolds, H., & Lawn, J. (2007). fGroup Prenatal Care and Perinatal Outcomes: A Randomized Controlled Trial. Obstetrics & Gynecology, 110(4), 993-994. doi:10.1097/01.AOG.0000275284.24298.23
Maternal Health Task Force, Harvard School of Public Health, et al. Group Care. Innovative Methods 2014.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03154177    
Other Study ID Numbers: A123218-Rw (UCSF RAS #)
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Pregnancy Complications
Stillbirth
Birth Weight
Obstetric Labor Complications
Body Weight
Fetal Death
Death
Pathologic Processes