A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Delivery rate (proportion)
研究概览
简要总结
The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.
详细描述
This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies presenting for preinduction ripening. Patients will be randomized to receive either TFC alone (control) or TFC plus low-dose oxytocin (treatment). Providers will not blinded to use of oxytocin and labor was managed according to routine obstetric protocols. This study is powered to detect a 20% difference in the proportion of patients delivered within 24 hours, the primary outcome. Secondary outcomes are related to vaginal delivery rate, duration of induction, complications, and pain management.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton gestation
- •presenting for induction as determined by their primary obstetrical provider
- •with fetuses in cephalic presentation
- •gestational age greater than 23 weeks
排除标准
- •any condition precluding vaginal delivery
- •estimated fetal weight >4500 grams
- •a previous attempt at ripening or induction during the pregnancy
- •clinically significant cervical or vaginal infection
- •chorioamnionitis
- •hepatitis B or C
- •unexplained vaginal bleeding
- •low-lying placenta
- •abnormal cervical anatomy or cervical cerclage
- •latex allergy
结局指标
主要结局
Delivery rate (proportion)
时间窗: Within 24 hours
次要结局
- vaginal delivery rate(within 24 hours)
- use of anesthesia/analgesia(during induction and labor)
- overall complication rate (composite)
- duration of induction and labor