Early Versus Late Amniotomy on Labour Induction in Nulliparous Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- successful induction
研究概览
简要总结
Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor.
Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable
详细描述
study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention model: two groups assignment masking: open lebal primary purpose: induction of labour actual study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date: March 20, 2020
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women at 36 weeks gestation or more
- •singleton fetus
- •cephalic presentation with common medical causes for labour induction e.g. intrauterine fetal growth restriction, post term pregnancy and preeclampsia.
排除标准
- •Macrocosmic babies with estimated fetal weight of more than 4000 gram
- •Previous uterine scars
- •Pre labor premature rupture of fetal membranes
- •Polyhydramnios.
研究组 & 干预措施
early amniotomy
Group A:
- Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached.
- Early amniotomy was performed for the participant of the first group at 3 cementer cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix.
干预措施: Misoprostol (Drug)
Late amniotomy
Group B:
- Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached.
- late amniotomy was performed for the participant of the second group at 7 cementer cervical dilatation.
干预措施: Misoprostol (Drug)
结局指标
主要结局
successful induction
时间窗: immediately after intervention
definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction
induction-delivery interval
时间窗: immediately after intervention
duration of labor and amniotomy delivery interval
次要结局
- Apgar score(during the intervention)
- misoprostol doses administered(during the intervention)
- the need for augmentation of labor(during the intervention)
- intrapartum meconium(during the intervention)
- newborn admission in the neonatal intensive care unit(immediately after intervention)
研究者
Mohamed Elsibai Anter
Lecturer of obstetrics and gynecology
Menoufia Obstetrics and Gynecology Group