The SWEEP Trial: a Randomized Controlled Trial
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About
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
Full description
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:
If possible, the first membrane sweeping will be performed during the routine antenatal visit at term. If not feasible, a separate consultation will be arranged. Two additional appointments will be scheduled as needed. Membrane sweeping is performed by inserting one or two fingers through the cervix and rotating them 2-5 times to separate the fetal membranes from the lower uterine segment. If the cervix is closed, cervical massage is performed externally with circular motions for approximately 15 seconds.
The intervention will continue until spontaneous labor begins or a maximum of three sweepings have been performed.
Participants in the control group will receive routine midwifery care but will be asked to avoid membrane sweeping until at least GA 41+3, unless medically indicated.
Inclusion criteria:
Singleton pregnant women at term with a fetus in cephalic presentation and an intended vaginal delivery.
Exclusion criteria:
< 18 years of age Unable to speak and understand Danish 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)
Outcomes:
The primary outcome is birth < GA 41+3 with spontaneous onset of labor.
Key secondary outcomes:
Risks and Side Effects:
There are no known serious risks associated with membrane sweeping for either the mother or baby.
Common and mild side effects may include:
Discomfort or mild pain during the procedure (the procedure can be stopped at any time upon request) Light spotting or brown discharge Braxton Hicks contractions
Informed Consent and Ethical Considerations:
Participants will receive both oral and written information in accordance with national and international ethical guidelines. Consent is obtained digitally via the REDCap platform using secure electronic signature technology.
Participants may withdraw consent at any time without consequence. All data are processed in accordance with the Danish Health Act and applicable GDPR regulations.
The study has been approved by the Regional Committees on Health Research Ethics for Central Denmark Region (journal number: 1-10-72-82-24 ) in accordance with Danish law and the Declaration of Helsinki.
Funding:
Funding for the trial is donated by:
Sundhedsdonationer from the Danish health insurance "danmark" with 7,000,000 DKK, The Health Research Foundation of Central Denmark Region with 100,000 DKK The Danish Association of Midwives with 45,931 DKK.
Additional funds will be sought to cover running costs during the trial. The investigators have no financial interests in the funding organizations.
Dissemination:
Study results will be published in international peer-reviewed journals and made publicly accessible in accordance with transparency requirements.
Enrollment
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Inclusion criteria
Singleton pregnant women at term with a fetus in cephalic presentation and an intended vaginal delivery.
Exclusion criteria
- < 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)
Trial design
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Allocation
Interventional model
Masking
1,536 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Sidsel Boie, PhD, MD, Consultant; Sofie Gyrup, PhD Student
Data sourced from clinicaltrials.gov
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