Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1536 participants
INTERVENTIONAL
2025-06-18
2027-10-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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
Membrane sweeping
Serial membrane sweeping from gestational age 39+5-40+2 with 2-3 days interval and a maximum og three times.
Interventions
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Membrane sweeping
Serial membrane sweeping from gestational age 39+5-40+2 with 2-3 days interval and a maximum og three times.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
40 Years
FEMALE
No
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Julie Glavind, PhD, Associate Professor, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital, Department of Obstetrics and Gynecology
Locations
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Aarhus University Hospital
Aarhus N, , Denmark
Aarhus University Hospital
Aarhus N, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The study's website
Other Identifiers
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1-10-72-82-24
Identifier Type: -
Identifier Source: org_study_id
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