Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both. Multicenter Randomized Controlled Trial- IDOM Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- the rate of cesarean delivery
研究概览
简要总结
The aim of this study is to compare the rate of cesarean delivery between 3 methods of labor induction: double balloon device, oral misoprostol and combination of the two.
详细描述
Induction of labor is a common obstetrical procedure. It accounts for 20% of laboring women worldwide.
In the past, studies showed that cesarean delivery rates (CDR) are higher in women who are induced. These studies were comparing induction to spontaneous labor, which is not the management in practice, and when the comparison was made between induction and expectant management, the conclusion was that the induction does not increase CDR and can even reduce its' rate.
Failure of induction depends on the definition, and even among randomized controlled trials, this definition may vary greatly.
The decision whether to use a mechanical or pharmacological agent depends on Bishop score, parity, contraindications to one of the methods and patient-doctor preference.
Recently, more data are available regarding induction with oral misoprostol (OM) and this method is becoming more popular because OM is effective, safe, convenient, cheap and easy to administer.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •unfavourable cervix (Bishop score ≤ 4),
- •indication for induction of labor (medical or obstetrical),
- •37 completed gestational weeks,
- •vertex presentation,
- •singleton pregnancy
- •intact membranes.
排除标准
- •previous cesarean delivery
- •previous uterine surgery (eg: myomectomy)
- •noncephalic presentation
- •multiple pregnancy
- •pre-eclampsia with severe features
- •oligohydramnios (Maximal vertical pocket ≤2)
- •estimated fetal weight <10% percentile
- •any contraindication to Vaginal delivery
研究组 & 干预措施
MISOPROSTOL
- oral misoprostol, 50 microgram, every 4 hours
- Repeat treatment every 4 hours until active labour begins: regular painful contractions (≥ 3 in 10 min), cervical dilatation ≥ 3 cm
- maximal number of doses: 6
- Oxytocin infusion can be initiated 4 hours after the last dose of Misoprostol.
- Failure of induction will be considered if no cervical change nor uterine contractions have begun during 24 hours of treatment.
- Electronic fetal monitoring should be performed for 30 min after administration of misoprostol and 60 min after any tachysystole.
干预措施: Misoprostol Oral Tablet (Drug)
DOUBLE BALLOON
- Insertion of the DBD as instructed by the manufacturer, removal after 6 hours.
- Artificial rupture of membranes (AROM) if suitable + IV oxytocin administration
- If AROM cannot be performed- oxytocin infusion will be initiated at first.
- If Bishop <3 after DBD removal, clinical evaluation and lag time before considering other methods for ripening is suitable and is up to the physician on call.
干预措施: double balloon device for cervical ripening (Device)
MISOPROSTOL+DOUBLE BALLOON
干预措施: Misoprostol Oral Tablet (Drug)
MISOPROSTOL+DOUBLE BALLOON
干预措施: double balloon device for cervical ripening (Device)
结局指标
主要结局
the rate of cesarean delivery
时间窗: from induction until delivery
percentage of cesarean delivery from all deliveries
次要结局
- Bishop score difference between groups(after 6 hours and after 24 hours)
研究者
Inna.bleicher
principle investigator
Bnai Zion Medical Center