Early External Cephalic Version 2 Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,543
- 试验地点
- 1
- 主要终点
- Rate of cesarean section
研究概览
简要总结
For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (CS)?
详细描述
Primary Outcomes: Rate of Caesarean section
Secondary Outcomes: Rate of preterm birth
Other Outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious fetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs.
The Data Coordination for this study is being carried out at the Maternal, Infant Reproductive Health Research Unit at Sunnybrook and Women's College Health Sciences Centre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with any breech presentation
- •A live singleton fetus
- •Gestational age of 33 weeks 0 days to 35 weeks 6 days
排除标准
- •Contraindications to ECV (e.g. fetal heart rate abnormalities, abruptio placenta, major life-threatening fetal anomalies, uterine anomalies, hyper-extended fetal head, rupture of membranes, severe oligohydramnios, severe polyhydramnios)
- •Contraindications to early ECV (e.g. increased risk of preterm labour [such as past history of preterm labour in this or previous pregnancies], increased risk of abruptio placenta [such as maternal hypertension])
- •Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS)
- •Women planning delivery by CS if the fetus turns to cephalic
- •Women planning a vaginal delivery if the fetus remains breech
- •Women at increased risk of unstable lie (eg. grand multiparity)
- •Previous participation in EECV2 Trial
研究组 & 干预措施
Early External Cephalic Version Group
Early external cephalic version (ECV) procedure performed between 34 weeks and 0/7 days and 35 weeks and 6/7 days of gestation
干预措施: Early ECV between 34 0/7 and 35 6/7 weeks (Procedure)
Delayed External Cephalic Version Group
Delayed external cephalic version (ECV) procedure performed at or after 37 weeks and 0/7 days of gestation
干预措施: Delayed ECV at or after 37 0/7 weeks (Procedure)
结局指标
主要结局
Rate of cesarean section
时间窗: Information not available
次要结局
- Rate of pre-term births. Other outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, or others.(Information not available)
研究者
Eileen Hutton
Professor, Department of Obstetrics & Gynecology
McMaster University