The SWEEP Trial - Serial Versus no Membrane Sweeping on Spontaneous Onset of Labor: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,536
- 试验地点
- 2
- 主要终点
- Number of Participants with Spontaneous Onset of Labor Resulting in Birth Before 41+3 Weeks of Gestation
研究概览
简要总结
The purpose of this clinical trial is to determine whether serial membrane sweeping at term is more effective than no membrane sweeping in promoting spontaneous onset of labor.
The primary research question is whether serial membrane sweeping increases the likelihood of birth before gestational age 41+3 with spontaneous onset of labor.
A total of 1536 participants will be randomized between gestational age 39+5 and 40+2 to either no membrane sweeping or up to three membrane sweepings performed 2-3 days apart.
Researchers will collect data from the electronic medical record and participants will be asked to complete a short daily questionnaire on pregnancy symptoms and, in the intervention group, their experience of membrane sweeping from randomization until birth. All participants will be asked to complete a follow-up questionnaire about their birth experience five weeks postpartum
详细描述
Background and Objective:
Membrane sweeping is a simple mechanical procedure used at term to promote spontaneous onset of labor by stimulating local prostaglandin release. Although it is widely used and generally considered safe, evidence for its effectiveness is limited and of low certainty. The SWEEP trial is a multicenter randomized controlled trial designed to address this gap by investigating whether serial membrane sweeping starting between GA 39+5 and 40+2 increases the likelihood of spontaneous labor before GA 41+3 compared to no membrane sweeping.
Study design:
This is a pragmatic, open-label, multicenter, randomized controlled trial conducted in public antenatal clinics in Denmark. A total of 1536 pregnant women with low-risk, singleton pregnancies will be randomized between GA 39+5 and 40+2 to either: No membrane sweeping, or serial membrane sweeping with 2-3 days interval, max. three times.
Intervention and Procedures:
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnant women at term with a fetus in cephalic presentation and an intended vaginal delivery.
排除标准
- •< 18 years of age
- •Unable to speak and understand Danish
- •Uncertain gestational age , defined as gestational age not determined by Crown-Rump-Length
- •Previous cesarean section
- •Ruptured membranes
- •Painful contractions
- •Vaginal bleeding more than bloody discharge
- •Membrane sweeping performed within the last two weeks
- •Already scheduled IOL or any known indication for IOL at or prior to GA 41+3 based on local or national guidelines
- •Known low-lying placenta (placenta located <3 cm from the internal orifice verified by transvaginal ultrasound)
研究组 & 干预措施
No membrane sweeping
Participants allocated to the control group will receive standard antenatal care, which does not include membrane sweeping prior to gestational age 41+3.
Membrane sweeping
Participants allocated to the intervention group will receive standard anetnatal care plus serial membrane sweeping starting from the time of allocation at gestational age 39+5 to 40+2. A total of up to three membrane sweepings will be scheduled, each with an interval of 2-3 calendar days
干预措施: Membrane sweeping (Procedure)
结局指标
主要结局
Number of Participants with Spontaneous Onset of Labor Resulting in Birth Before 41+3 Weeks of Gestation
时间窗: From randomization until time of birth. Assessed at birth
Participants meet the primary outcome if they give birth before gestational age 41 weeks and 3 days, and labor starts spontaneously-defined as either prelabor rupture of membranes (PROM) or contractions leading to cervical dilation, without the use of medical or mechanical induction methods (including artificial rupture of membranes before 4 cm dilation) and without a cesarean section before labor begins
次要结局
- Mode of Delivery(From onset of labor to time of birth)
- Early Labor Experience(4-6 weeks postpartum)
- Undelivered at Gestational Age 41+3(From randomization until time of birth. Assessed at birth.)
- Gestational Age at Delivery(From randomization until time of birth. Assessed at birth)
- Randomization to Delivery Interval(From date of randomization until the date of birth, assessed up to 21 days)
- Duration of Labor(From onset of labor (self-reported contractions or spontaneous rupture of membranes) until time of birth.)
- Duration of Active Labor(From active phase of labor to time of birth)
- Induction Of Labor (IOL)(From date of randomization until time of birth. Assessed within 21 days.)
- Indication for Induction of Labor(From date of randomization until time of birth. Assessed within 21 days.)
- Spontaneous Rupture of Membranes(From date of randomization until time of birth. Assessed within 21 days.)
- Use of Oxytocin Augmentation(From active phase of labor to time of birth)
- Intrapartum Temperature equal to or greater than 38.0 degrees Celsius(From labor onset to time of birth)
- Epidural Analgesia During Labor(From labor onset to time of birth)
- Childbirth Experience(4-6 weeks postpartum)