Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6 : a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time to active phase of labor
研究概览
简要总结
Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth.
A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health.
Combined with oxytocin infusion, amniotomy is commonly used in the induction of labor. However the perfect timing of amniotomy is still unknown.
The aim of this study is to determine whether the early amniotomy followed by oxytocin, or initiating induction of labor with oxytocin followed by late amniotomy, is effective to reach active phase of labor.
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
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old
- •Full term (36 weeks and 3 days of gestation reached)
- •Singletion gestation in cephalic presentation
- •Bishop score of ≥ 6
排除标准
- •Prior uterine surgery, previous cesarean section
- •Ruptured membranes
- •Spontaneous labor
- •Multifetal pregnancy
- •Dystocic presentation
- •Fetal head not fixed at pelvic brim
- •Macrosomia
- •Hydramnios
- •Severe fetal growth restriction
- •Major fetal anomaly
- •Women with HIV, hepatitis C, hepatitis B
- •Women with medical conditions contraindication to a vaginal delivery
- •Women with COVID-19 infection
结局指标
主要结局
Time to active phase of labor
时间窗: At delivery
Total time from initiation oxytocin infusion to reaching 5 cm cervical dilation
次要结局
- Time to vaginal delivery(At delivery)
- Maternal outcomes(From inclusion to discharge, up to 2 weeks)
- Cesarean delivery rate(At delivery)
- Fetal and neonatal outcome(From inclusion to discharge, up to 2 weeks)
研究者
Ahmed Halouani
MD
University Tunis El Manar