Randomized Controlled Trial: Cervical Ripening Balloon With and Without Oxytocin for Cervical Ripening in Multiparas
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Time From Cervical Ripening to Delivery
研究概览
简要总结
Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix.
Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.
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
- •Age > 18 years
- •Gestational age > 34 + 0/7 weeks
- •Prior spontaneous vaginal delivery
- •Clinical or U/S EFW of <4500 grams
- •Singleton gestation
- •Cervical dilation <2 cm
排除标准
- •Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery
- •Placenta within 2 cm of cervical os
- •Placental abruption, chorioamninoitis, or systemic infection prior to induction
- •Rupture of membranes prior to induction ->1 prior C/S
研究组 & 干预措施
Cervical Ripening Balloon Alone
Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
干预措施: Oxytocin (Drug)
Cervical Ripening Balloon + Oxytocin
Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Time From Cervical Ripening to Delivery
时间窗: Time to delivery
Time from placement of cervical ripening balloon to delivery
次要结局
未报告次要终点