Membrane Sweeping in Early Labor and Delivery Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Decrease in Cesarean delivery rate
研究概览
简要总结
Membrane sweeping is a routine procedure in obstetrics in term patients. It has been shown to be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal delivery when used in setting of induction of labor in nulliparous patients. The goal of this study is to determine if membranes sweeping in early labor is effective in improving delivery outcomes including decreasing rate of cesarean section.
详细描述
This is a non-blinded randomized controlled trial. Participants will be recruited at time of presentation to triage for labor evaluation after cervical exam. Patients with a term, singleton pregnancy who present with regular, painful contractions and a Bishop score < 7 will be recruited to the study. A random number generator will be used to create a list of random binary numbers. If the patient agrees to the study, the random number list will be used to assign the participant to membrane sweeping or no membrane sweeping. Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise. Those not assigned to membrane sweeping will not have an additional exam. Patients will then be managed as per their primary Obstetrics (OB) provider with the exception of no further membrane sweeping throughout the labor course.
Participants are only required to participate during initial evaluation and randomization. No extra study visits are required.
Due to the nature of the intervention, which requires a provider to perform a procedure, blinding will not be possible for this trial.
No therapy will be withheld for any patients. Their labor course will be managed as per their primary provider using standards of care.
Non-treatment group is necessary in order to exam the difference of effects between membrane sweeping and no membrane sweeping.
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
盲法说明
Intervention is not able to be blinded
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy at or after 39 weeks gestation, intact membranes, cephalic presentation, nulliparous, Bishop score <7, English or Spanish speaking
排除标准
- •Prior uterine surgery precluding vaginal delivery, maternal condition precluding vaginal delivery, fetal anomaly, prior membrane stripping
研究组 & 干预措施
Membrane Sweeping
Membrane sweeping
干预措施: Membrane sweeping (Procedure)
Control
Routine vaginal exam
结局指标
主要结局
Decrease in Cesarean delivery rate
时间窗: Up to 3 weeks
Decrease in Cesarean delivery rate
次要结局
- Operative vaginal delivery rate(Up to 3 weeks)
- Labor augmentation rate reduction(Up to 3 weeks)
- Time to delivery(Up to 3 weeks)