Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Bishop Score
研究概览
简要总结
The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook balloon.
详细描述
Upon presentation for cervical ripening appointment, a sterile vaginal exam will be completed to assign Bishop score, as per standard routine. Once the patient has been consented and randomized, the participant will have a Cook catheter or Dilapan-S inserted. For the Cook catheter, the uterine component of the balloon will be inflated to maximum 60mL, the vaginal balloon will not be inflated per standard practice and per the literature that shows slightly increased pain and negligible improvement in cervical ripening. The catheter will be taped to the inner thigh with gentle traction. For Dilapan-S, 3-5 dilators will be placed.
After placement, the patient will be discharged home with strict return precautions per the outpatient cervical ripening protocol. Patients must return to labor and delivery within 24 hours of cervical ripening agent placement at their scheduled inpatient induction time.
Upon return to labor and delivery, if not already expelled, the mechanical ripening device will be removed, and an examiner blinded to the cervical ripening method will complete a sterile vaginal exam to assign a Bishop score.
At that point health care providers will manage active labor per usual practice. Labor interventions are at the discretion of the healthcare provider. The need for operative delivery or cesarean section will be at the discretion of the healthcare provider.
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
- Single (Care Provider)
盲法说明
Physician performing the cervical exams will be blinded to the patient's study arm
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-50 years of age
- •Term (37-41 6/7 weeks gestational age)
- •Low risk (i.e. without any maternal or fetal co-morbidity) and who are candidates for outpatient cervical ripening per the Brigham and Women's outpatient cervical ripening protocol
- •Singleton pregnancy
- •Cephalic presentation
排除标准
- •Prior cesarean section
- •Any contraindication to outpatient cervical ripening per Brigham and Women's outpatient cervical ripening protocol
- •Non-English-speaking
结局指标
主要结局
Change in Bishop Score
时间窗: Up to 24 hours
Difference in Bishop score calculated from exam at time of device removal minus Bishop score calculated from exam at time of device placement. Bishop score, or cervical score, ranges from a minimum of 0 to maximum of 13. Higher scores indicate that the cervix is more favorable, or ready for labor. Thus, change in Bishop score could range from -13 to +13 with a higher number showing more change in the score, or more cervical ripening.
次要结局
- Composite Maternal Morbidity: Morbidity, no Morbidity(Assessed at end of study period (week 4))
- Mode of Delivery: Vaginal Delivery, Cesarean Delivery(Assessed at the time of delivery, within 1 week)
- Cervical Ripening Success Score: No Failure, Failure(Assessed at the time of device removal, within 24 hours)
- Composite Neonatal Morbidity: Morbidity, no Morbidity(Assessed at end of study period (week 4))
- Patient Satisfaction(Assessed upon device removal, within 24 hours)
- Time on Labor and Delivery(Assessed at the time of delivery, within 1 week)
- Maternal Length of Stay(Assessed at end of study period (week 4))
研究者
Sarah E Little
Clinical Instructor
Brigham and Women's Hospital