Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction
试验速览
- 阶段
- 3 期
- 入组人数
- 320
- 主要终点
- Time from second agent induction to delivery
研究概览
简要总结
Induction of labor is one of the most common obstetrical medical procedures performed today. Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is undertaken for various maternal and fetal indications and spans 20% of deliveries today.
- During the past years there has been an additional rise due to elective inductions
- Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks of induced delivery, particularly those associated with post-term pregnancy, rupture of membranes, oligohydramnios and additional fetal and maternal conditions that pose risks to mother and fetus.
In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less) sequential induction with more than one agent is necessary. To date, no trial has compared the optimal subsequent ripening method after the preliminary use of dinoprostone (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of subsequent induction in women admitted for induction of labor with Bishop score <7 or less 24 hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of routine induction of labor will be compared: An additional Propess induction for another 24 hours vs. intravenous oxytocin infusion combined with intra-cervical balloon insertion.
详细描述
Induction of labor is one of the most common obstetrical medical procedures performed today. Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is undertaken for various maternal and fetal indications and spans 20% of deliveries today
- During the past years there has been an additional rise due to elective inductions
- Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks of induced delivery, particularly those associated with post-term pregnancy, rupture of membranes, oligohydramnios and additional fetal and maternal conditions that pose risks to mother and fetus.
In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less) sequential induction with more than one agent is necessary. To date, no trial has compared the optimal subsequent ripening method after the preliminary use of dinoprostone (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of subsequent induction in women admitted for induction of labor with Bishop score <7 or less 24 hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of routine induction of labor will be compared: An additional Propess induction for another 24 hours vs. intravenous oxytocin infusion combined with intra-cervical balloon insertion.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Maternal age of 18 years or greater
- •Singleton gestation
- •Bishop score of 7 or less 24 hours after the insertion of Propess
- •Pregnancies at 36+0/7 weeks of gestation and beyond
- •Normal fetal heart rate tracings and normal sonogram at admission (ie Vertex, appropriate for gestational age, biophysical score of 8/8, normal amniotic fluid index)
- •No contraindication for prolongation of pregnancy (e.g. intrauterine infection, placental abruption, etc.)
排除标准
- •Situations preventing continuation of induction process in any arm - patient refusal, maternal of fetal conditions necessitating prompt delivery.
- •Rupture of membranes (ROM) after initial Propess insertion.
研究组 & 干预措施
Administration of Propess
All women who failed induction of labor using vaginal insert slow release of dinoprostone 10 mg (Propess), defined as bishop score ≤ 7 24 hours after propess insertion will be randomized to one of the following treatment arms:
1.Administration of Propess for additional 24 hours.
干预措施: Administration of Propess (Drug)
Intravenous oxytocin infusion + balloon
All women who failed induction of labor using vaginal insert slow release of dinoprostone 10 mg (Propess), defined as bishop score ≤ 7 24 hours after propess insertion will be randomized to one of the following treatment arms:
- Intravenous oxytocin infusion combined with intracervical balloon administration, inflated with 60cc of saline.
干预措施: balloon (Device)
Intravenous oxytocin infusion + balloon
All women who failed induction of labor using vaginal insert slow release of dinoprostone 10 mg (Propess), defined as bishop score ≤ 7 24 hours after propess insertion will be randomized to one of the following treatment arms:
- Intravenous oxytocin infusion combined with intracervical balloon administration, inflated with 60cc of saline.
干预措施: Intravenous oxytocin infusion (Drug)
结局指标
主要结局
Time from second agent induction to delivery
时间窗: 48 hours
Time from second agent induction to active labor
次要结局
- Rate of failed induction defined as 5 cm dilatation(48 hours)
- Rate of failed induction defined as regular contractions(48 hours)
- cesarean sections rate(48 hours)