Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- 1 Minute Apgar Score of Trial of Labor After Cesarean Section
研究概览
简要总结
The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to indicate ideal time of placement for optimal cervical ripening prior to induction. The proposed study is a randomized control trial to determine if shortening placement from 12 to 6 hours of foley catheter can decrease time from start of induction to delivery. The prediction is that shortening foley bulb placement will result in shorter induction times, increased patient satisfaction and decreased length of stay on labor and delivery with secondary decreased medical costs.
详细描述
Objective: To determine whether a double-lumen balloon catheter requires twelve hours in the cervical canal to achieve its maximal cervical dilation. It is the hypothesis that the maximum cervical dilation and benefits of a double lumen foley catheter are achieved within the initial six hours after placement.
Study Design:
Overview: All eligible patients with a singleton pregnancy at 37 weeks gestational age or greater who are presenting for a clinically/ medically indicated induction with an unfavorable cervical exam will be invited to participate. As per the American College of Obstetricians and Gynecologists (ACOG) guidelines, all inductions performed prior to 39 weeks are medically indicated. Medical indications for induction prior to 39 weeks include but are not limited to preeclampsia, oligohydramnios and growth restriction. Upon admission to Labor and Delivery, women will be assessed for eligibility by an obstetric physician. A digital cervical examination will be performed and a Bishop score assigned. Patients with a Bishop score ≤ 6 are thought to benefit from a cervical ripening agent and the participants will be randomized based on parity at this point.
Type of Study: This study will be a prospective, randomized clinical control trial with human subjects.
Materials and Methods:
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
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Intrauterine pregnancy at 37 weeks gestational age or greater as determined by best obstetrical dating criteria
- •Singleton gestation
- •Vertex presentation
- •Clinically adequate pelvis
- •Bishop Score less than or equal to 6
- •16 years and older
- •North Carolina state law provides for the emancipation of minors, Chapter 7B-Article 35.
排除标准
- •Any maternal or fetal contraindication to vaginal delivery
- •Known uterine anomaly
- •Multifetal gestation
- •Estimated fetal weight of 4500 gm or greater
- •Ruptured membranes
结局指标
主要结局
1 Minute Apgar Score of Trial of Labor After Cesarean Section
时间窗: 1 minute Apgar score following birth
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Time to Delivery of Trial of Labor After Cesarean Section
时间窗: Time (hours) to delivery
Time From Foley Bulb Placement to Time of Delivery.
时间窗: Change in time to delivery following bulb insertion for 6 hours up to 72 hours
Time in hours to delivery following use of foley catheter
次要结局
- Mode of Delivery--Number of Participants Having Cesarean Delivery(Hour Six, Hour 12)
- 1 Minute Apgar Score(1 minute Apgar score following birth)
- Time to Foley Bulb Extrusion of Trial of Labor After Cesarean Section(Time to foley bulb extrusion)
- Endometritis(Hour 6, Hour 12)
- Bacterial Infection (Chorioamnionitis)(Hour Six, Hour 12)
- 5 Minute Apgar Score(5 minute Apgar score following birth)
- Time From Foley Bulb Placement to Extrusion(Hour 6, Hour 12)
- 5 Minute Apgar Score of Trial of Labor After Cesarean Section(5 Minute Apgar Score following birth)