Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- induction delivery interval (time from starting induction to delivery)
研究概览
简要总结
to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor
详细描述
two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Indication for labour induction Term pregnancy with alive fetus Bishop score less than five
排除标准
- •Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina
研究组 & 干预措施
sequential
sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor.
干预措施: Misoprostol (Drug)
sequential
sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor.
干预措施: Foley Catheter (Device)
Concurrent
Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor.
干预措施: Misoprostol (Drug)
Concurrent
Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor.
干预措施: Foley Catheter (Device)
结局指标
主要结局
induction delivery interval (time from starting induction to delivery)
时间窗: 48hours
safety issue
次要结局
- Severe neonatal morbidity or perinatal death(28 days)
- Cesarean section(72h)
- Serious maternal morbidity or maternal death(42 days)
- Need of oxytocin for augmentation of labour(48h)
- Number of doses needed to bring on labour(48h)
- Hyperstimulation syndrome(24h)
- Failed induction (failure to elicit contraction after 72 hours)(72h)
研究者
IBRAHIM ABD ELGAFOR
assistant lecturer
Zagazig University