Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert - a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 253
- 试验地点
- 7
- 主要终点
- time interval from primary treatment to delivery
研究概览
简要总结
The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not greater than 6) compared to medical treatment using a dinoprostone slow-release-vaginal-insert.
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
- 否
入选标准
- •medical indication for induction of labor
- •18 years of age
- •signed informed consent
- •cephalic presentation
- •37+0 - 42+0 weeks of gestation
- •Bishop-Score ≤ 6
- •no contra-indication for medical induction of labor
- •no clinical signs of infection
排除标准
- •fetal anomalies
- •contra-indications for medical induction of labor
- •placental pathologies
- •St.p. surgery with opening the uterine cavity (incl. caesarean section)
- •multiple gestations
- •< 37-0 weeks of gestation
- •St.p. cervical tear
研究组 & 干预措施
Cervical ripening balloon
primary treatment with the cervical ripening balloon on day 1. removal of the balloon latest after 12 h. If no progression of labor (Bishop Score ≥ 9 and/or cervical opening ≥ 3 cm) continuing of standard treatment using dinoprostone vaginal-inserts on day 2 and if necessary on day 3.
干预措施: Cervical Ripening Balloon, Cook Medical Inc. (Device)
Propess
Primary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm)
干预措施: Dinoprostone (Drug)
结局指标
主要结局
time interval from primary treatment to delivery
时间窗: maximum of 72 hours
the time interval between the first application of the cervical ripening balloon (therapy arm 1) to delivery and the time between first application of dinoprostone vaginal-insert (therapy arm 2) to delivery is measured
次要结局
- progress of labor(maximum of 72 hours)
- vaginal delivery(maximum of 72 hours)
- failed induction of labor(maximum of 72 hours)
- maternal parameters(primary treatment - 48h postpartal, leading to a maximum time frame of 5 days)
- fetal parameters(primary treatment - fetal hospital discharge, with an expected maximum of 3 months)
- patient's satisfaction(participants will be followed for the duration of hospital stay, an expected average of 5-7 days)