A Matched-pair, Cluster Randomized Trial to Measure the Efficacy of the WHO Safe Childbirth Checklist Program on Severe Maternal, Fetal and Newborn Harm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157,689
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
研究概览
简要总结
The purpose of this study is to measure the impact of a checklist-based childbirth safety program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in north India.
详细描述
The WHO Safe Childbirth Checklist Program is a quality improvement program designed to support health workers to deliver evidence-based practices to women and newborns around the time of institutional childbirths. At the program's core is the Safe Childbirth Checklist, a 31-item list of essential practices that target the major causes of maternal and newborn mortality in low-resource settings globally. The program was developed over 3 years by a partnership of WHO and HSPH, working with a large international network of experts and stakeholders in maternal, fetal, and newborn health. Pilot testing of the program at a public-sector birth center in south India demonstrated dramatic improvements in health worker adherence to essential childbirth-related clinical care standards. The current study is a matched-pair, cluster randomized trial to measure the efficacy of the program in reducing severe maternal and newborn harm. This trial will be conducted at approximately 120 health facilities in Uttar Pradesh, India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For measuring outcomes, inclusion criteria are all mothers admitted to a study site for childbirth and newborn babies who are to be followed-up. In case a mother or baby from an enrolled site is referred out to another facility (before or after delivery) the mother-baby dyad will be included in the study and the outcome will be allocated to the referring facility
- •For a smaller subset of birth events (approximately 4,650 deliveries total), health worker practices will be observed to measure the impact of the SCC program on delivery of essential practices, as a secondary outcome. A convenience sample of women who agree to observation and their babies cared for by the health workers around the time of childbirth at the facility during data collectors' duty hours will be included in this component of the study.
排除标准
- •Mothers who have been referred into the facility by an inter-facility transfer.
- •Mothers being managed for abortion.
- •Mothers who refuse consent for follow-up
结局指标
主要结局
Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
时间窗: 0-7 days after delivery
The primary outcome was a composite outcome of events occurring within the first 7 days after delivery, incorporating stillbirth; early neonatal death; maternal death; or self-reported maternal severe complications, including seizures, loss of consciousness for more than 1 hour, fever with foul-smelling vaginal discharge, hemorrhage, or stroke.
次要结局
- Count of Participants With Newborn Referral(0-7 days after delivery)
- Count of Participants With Perinatal Death Within 7 Days(0-7 days)
- Count of Participants With Stillbirth(0-7 days after delivery)
- Count of Participants With Hysterectomy Within 7 Days(0-7 days after delivery)
- Count of Mothers Returning to Facility for a Health Problem Within 7 Days(0-7 days after delivery)
- Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days(0-7 days after delivery)
- Count of Participants With Maternal Referral, Before or After Delivery(0-7 days after delivery)
- Count of Participants With Early Neonatal Death(0-7 days after delivery)
- Count of Participants With Maternal Death(0-7 days after delivery)
- Count of Participants With Cesarean Section(Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary))
- Count of Newborns Returning to Facility for a Health Problem Within 7 Days(0-7 days after delivery)
- Count of Participants With Severe Maternal Complications(0-7 days after delivery)
- Count of Participants With Blood Transfusion Within 7 Days(0-7 days after delivery)
研究者
Katherine Semrau
Principal Investigator
Harvard School of Public Health (HSPH)