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临床试验/NCT03154177
NCT03154177已完成不适用

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

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 26,381 人开始时间: 2017年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26,381
试验地点
2
主要终点
Gestational Age

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 64 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group ANC and PNC only

Experimental

Health facilities randomized to provide group ANC/PNC.

干预措施: Group ANC/PNC (Behavioral)

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.

干预措施: Ultrasound+Pregnancy Testing (Procedure)

Group Care + Ultrasound+Pregnancy Testing

Experimental

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

干预措施: Group ANC/PNC (Behavioral)

Group Care + Ultrasound+Pregnancy Testing

Experimental

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

干预措施: Ultrasound+Pregnancy Testing (Procedure)

结局指标

主要结局

Gestational Age

时间窗: 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.

次要结局

  • Preterm 28-day and 42-day mortality rate(28 days and 42 days post delivery)
  • Preterm birth rate(At delivery)
  • 1st ANC visit during the first trimester(up to 14 weeks gestation)
  • Newborns with neonatal morbidities, specifically, jaundice, rapid breathing, fever, pneumonia, hypothermia, and/or cord infection(28 days post delivery)
  • Adherence to 6 week postnatal visit(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)
  • C-section deliveries(At Delivery)
  • High-risk Women(From the day of first ANC visit at the health center until the day of delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Group Antenatal/Postnatal Care in Rwanda | 临床试验