The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88,918
- 试验地点
- 2
- 主要终点
- Rate of Cesarean section
研究概览
简要总结
This project is a clustered randomized controlled trial of a knowledge translation intervention of new ACOG guidelines for the diagnosis of poor progress in labor. The intent is to reduce the rate of cesarean section (CS) in first time mothers at term (>= 37 weeks), with a vertex presenting singleton fetus, without increasing maternal or neonatal morbidity. The guidelines were developed from data from the Consortium for Safe Labor. The unit of randomization will be sites in Alberta that deliver
详细描述
Cluster randomized controlled trial of a knowledge translation intervention of new guidelines for the diagnosis of poor progress in labor. The intervention will be randomized to centres (the clusters) in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually, with stratification based on facility type and geographic location. Clustering by centre and not individual caregivers (nurses/physicians) is necessary to prevent leakage or crossover of the intervention to controls. As all participating centres will eventually receive the intervention, the biostatistician will generate a randomization into two "waves". The intervention will be introduced sequentially by strata (Calgary, Edmonton, regional centres, rural centres) to the first "wave" hospitals in multi-week run-in periods after which those strata will be revisited for roll-out to the second "wave" hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Centers in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually
排除标准
- 未提供
结局指标
主要结局
Rate of Cesarean section
时间窗: at delivery
Rate of Cesarean section in primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus
次要结局
- Rate of perinatal death(at delivery)
- Rate of postpartum hysterectomy(Within 30 days of delivery)
- Rate of post partum hemorrhage(at delivery)
- Rate of postpartum uterine artery/pelvic artery embolization(Within 30 days of delivery)
- Rate of blood transfusion(at delivery)
- Rate of postpartum maternal intensive care unit (ICU) admission(at delivery)
- Rate of neonatal asphyxia(at delivery)
- Rate of moderate or severe asphyxia or meets criteria for therapeutic cooling(at delivery)
- Rate of neonatal sepsis or suspected sepsis(at delivery)
研究者
Stephen Wood
Professor
University of Calgary