The Twin Birth Study: A Multicentre Randomised Controlled Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of Twins More Than or Equal to 32 Weeks Gestation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,804
- 试验地点
- 2
- 主要终点
- Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
研究概览
简要总结
For twin pregnancies at 32-38 weeks gestation, where twin A is head down, does a policy of planned caesarean section (CS) lower the likelihood of death or serious illness, during the first 28 days after birth, compared to a plan for vaginal birth (VB)?
详细描述
For twin pregnancies of 32-38 weeks gestation, where twin A is presenting cephalic, does a policy of planned CS decrease the likelihood of perinatal or neonatal mortality or serious neonatal morbidity, during the first 28 days after birth, compared to a policy of planned VB?
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
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at 32 0/7 - 38 6/7 weeks gestation
- •Estimated fetal weight of each fetus 1500 - 4000 g
- •Both twins alive at time of randomization
- •Twin A is in cephalic position
排除标准
- •Monoamniotic twins
- •Lethal fetal anomaly of either fetus
- •Contraindication to labour or vaginal delivery for either twin
- •Previous participation in the Twin Birth Study
结局指标
主要结局
Perinatal/Neonatal Mortality and/or Serious Neonatal Morbidity
时间窗: until 28 days after delivery
The primary outcome was a composite of fetal or neonatal mortality or serious neonatal morbidity.
次要结局
- Death or Poor Neurodevelopmental Outcome of the Children at 2 Years of Age (Corrected for Gestational Age at Birth)(2 years)
- Neonatal Morbidity(until 28 days after delivery)
- Problematic Urinary or Faecal/Flatal Incontinence of Mothers at 2 Years Postpartum(2 years postpartum)
研究者
Dr Jon Barrett
Chief, Maternal-Fetal Medicine
Sunnybrook Health Sciences Centre