NCT01170819已完成4 期
Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.
Università degli Studi dell'Insubria1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Vaginal delivery within 24 hours
研究概览
简要总结
To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.
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
- •singleton gestation
- •gestational age greater than 34 weeks
- •cephalic presentation
- •intact membranes
- •Bishop score of ≤4
- •reactive fetal heart rate (FHR) pattern on admission
排除标准
- •any condition precluding vaginal delivery
- •any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease
- •previous cesarean section or other uterine incision
研究组 & 干预措施
Dinoprostone Vaginal Insert
Active Comparator
干预措施: Dinoprostone 10 mg controlled-release vaginal insert (Drug)
Double Balloon Catheter
Experimental
干预措施: Double balloon catheter (Device)
结局指标
主要结局
Vaginal delivery within 24 hours
时间窗: 24 hours from start of cervical ripening
次要结局
- Cesarean section rate(48 hours from start of ripening)
- Uterine hyperstimulation(12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening)
- Onset of active labor(36 hours from start of ripening)
研究者
Antonella Cromi
PhD
Università degli Studi dell'Insubria
研究点 (1)
Loading locations...
相似试验
招募中
不适用
DOuble-BAlloon Versus PROstaglandin E2 for Cervical Ripening in Low Risk PregnanciesInduction of LaborNCT04747301Hanoi Obstetrics and Gynecology Hospital540
已完成
2 期
Combined Foley Catheter Balloon and PGE2 Vaginal Ovule for Induction of Labor at Term: A Randomized StudyUnfavorable Cervix, Cervical RipeningNCT02861079Zeynep Kamil Maternity and Pediatric Research and Training Hospital300
Unknown
2 期
Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical RipeningLabor InductionNCT03016442Kanuni Sultan Suleyman Training and Research Hospital200
已完成
不适用
Foley Catheter vs Double-balloon CatheterPregnancy TerminationCatheterNCT03521674Kanuni Sultan Suleyman Training and Research Hospital100
已完成
4 期
Induction of Labor in Term Pregnancies With Unfavourable CervixInduction of Labor Affected Fetus / NewbornProstaglandins Causing Adverse Effects in Therapeutic UseNCT04280874Clinical Hospital Merkur212