Membrane StrippingNCT07043088
The SWEEP Trial: a Randomized Controlled Trial
A study testing Membrane sweeping in people with Membrane Stripping and Cervical Ripening, run by University of Aarhus at 2 sites in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Membrane Stripping, Cervical Ripening, Memrane Sweeping
- What is being tested?
- Membrane sweeping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,536 participants
- Where
- 2 sitesDenmark
- Study dates
- 18 Jun 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnant women at term with a fetus in cephalic presentation and an intended vaginal delivery.
Who cannot join
- < 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
Show all 10Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus N, 8200
Sofie Gyrup, PhD Student, Midwife, +4522428032, sofnil@rm.dk
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Sofie Gyrup, PhD Student, Midwife, 004522428032, sofnil@rm.dk
About this study
Official title: The SWEEP Trial - Serial Versus no Membrane Sweeping on Spontaneous Onset of Labor: a Randomized Controlled Trial
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.
Read more
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
Read the detailed 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.
- Conditions
- Membrane Stripping, Cervical Ripening, Memrane Sweeping
- Being tested
- Membrane sweeping
- Keywords
- membrane sweeping, cervical ripening, labor onset, term pregnancy, induction of labor, midwifery, randomized controlled trial, post-term pregnancy, membrane stripping
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Membrane sweepingProcedure or surgery
Also called Intervention group
Serial membrane sweeping from gestational age 39+5-40+2 with 2-3 days interval and a maximum og three times.
| Study group | Role | What they receive |
|---|---|---|
| No membrane sweeping | No intervention | 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 | Experimental | 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 Receives: Procedure: Membrane sweeping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Spontaneous Onset of Labor Resulting in Birth Before 41+3 Weeks of Gestation
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
Measured: From randomization until time of birth. Assessed at birth
Secondary outcomes (14)
Undelivered at Gestational Age 41+3
Still pregnant when entering the calendar date of GA 41+3 (deliveries at 41+3 counts as undelivered)
Measured: From randomization until time of birth. Assessed at birth.
Gestational Age at Delivery
Length of gestation at birth in days
Measured: From randomization until time of birth. Assessed at birth
Randomization to Delivery Interval
Hours from randomization to birth
Measured: From date of randomization until the date of birth, assessed up to 21 days
Duration of Labor
Hours from selfreported starting time of contractions or spontaneous rupture of membranes till time of birth
Measured: From onset of labor (self-reported contractions or spontaneous rupture of membranes) until time of birth.
Duration of Active Labor
Minutes from active phase of labor registered in the electronic medical journal to time of birth or minutes from 4-6 cm of cervical dilation and painful contractions to time of birth.
Measured: From active phase of labor to time of birth
Induction Of Labor (IOL)
Labor started with any induction method including AROM <4 cm
Measured: From date of randomization until time of birth. Assessed within 21 days.
Indication for Induction of Labor
IOL due to:
- Late term pregnancy (from GA 41+3-)
- Maternal request
- Maternal medical indication
- Fetal indication
- Other indications
Measured: From date of randomization until time of birth. Assessed within 21 days.
Spontaneous Rupture of Membranes
Spontaneous rupture of membranes as primary labor onset occurring before contractions
Measured: From date of randomization until time of birth. Assessed within 21 days.
Use of Oxytocin Augmentation
Use of oxytocin augmentation during labor from more than 4 cm of cervical dilatation
Measured: From active phase of labor to time of birth
Intrapartum Temperature equal to or greater than 38.0 degrees Celsius
Two rectal temperature measurements of 38.0 degrees Celsius or higher, taken at least 30 minutes apart
Measured: From labor onset to time of birth
Epidural Analgesia During Labor
Administration of epidural from onset of labor till time of birth
Measured: From labor onset to time of birth
Mode of Delivery
Spontaneous vaginal delivery; no use of vacuum or forceps. Instrumental vaginal delivery: use of vacuum or forceps. Caesarean section: scheduled or acute
Measured: From onset of labor to time of birth
Early Labor Experience
Self-reported early labor experience measured using the validated Early Labor Experience Questionnaire (ELEQ); total and subscale scores calculated
Measured: 4-6 weeks postpartum
Childbirth Experience
Self-reported childbirth experience measured using the validated Childbirth Experience Questionnaire (CEQ); total and subscale scores calculated.
Measured: 4-6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start18 Jun 2025
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Membrane StrippingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Julie Glavind, PhD, Associate Professor, MD, Principal investigator, Aarhus University Hospital, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043088
- Sponsor's protocol ID
- 1-10-72-82-24
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available from the corresponding author upon reasonable request and in accordance with Danish data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SWEEP Trial - Serial Versus no Membrane Sweeping on Spontaneous Onset of Labor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07043088
- Acronym / sponsor ID
- 1-10-72-82-24
- Conditions
- Membrane Stripping, Cervical Ripening, Memrane Sweeping
- Keywords
- membrane sweeping, cervical ripening, labor onset, term pregnancy, induction of labor, midwifery, randomized controlled trial, post-term pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,536 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No membrane sweeping | No intervention | –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 | Experimental | Procedure: Membrane sweepingParticipants 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Singleton pregnant women at term with a fetus in cephalic presentation and an intended vaginal delivery.
Key exclusion criteria (10 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Membrane sweepingAlso: Intervention groupSerial membrane sweeping from gestational age 39+5-40+2 with 2-3 days interval and a maximum og three times. | Procedure or surgery | Membrane sweeping |
Primary outcome
Number of Participants with Spontaneous Onset of Labor Resulting in Birth Before 41+3 Weeks of Gestation
Time frame: 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
14 secondary outcomes
Undelivered at Gestational Age 41+3
Time frame: From randomization until time of birth. Assessed at birth.
Gestational Age at Delivery
Time frame: From randomization until time of birth. Assessed at birth
Randomization to Delivery Interval
Time frame: From date of randomization until the date of birth, assessed up to 21 days
Duration of Labor
Time frame: From onset of labor (self-reported contractions or spontaneous rupture of membranes) until time of birth.
Duration of Active Labor
Time frame: From active phase of labor to time of birth
Induction Of Labor (IOL)
Time frame: From date of randomization until time of birth. Assessed within 21 days.
Indication for Induction of Labor
Time frame: From date of randomization until time of birth. Assessed within 21 days.
Spontaneous Rupture of Membranes
Time frame: From date of randomization until time of birth. Assessed within 21 days.
Use of Oxytocin Augmentation
Time frame: From active phase of labor to time of birth
Intrapartum Temperature equal to or greater than 38.0 degrees Celsius
Time frame: From labor onset to time of birth
Epidural Analgesia During Labor
Time frame: From labor onset to time of birth
Mode of Delivery
Time frame: From onset of labor to time of birth
Early Labor Experience
Time frame: 4-6 weeks postpartum
Childbirth Experience
Time frame: 4-6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- The study's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data are available from the corresponding author upon reasonable request and in accordance with Danish data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Glavind, PhD, Associate Professor, MD principal investigator
Aarhus University Hospital, Department of Obstetrics and Gynecology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Membrane sweeping in people with Membrane Stripping and Cervical Ripening, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofie Gyrup, PhD Student (+4522428032, sofiegyrup@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Spontaneous Onset of Labor Resulting in Birth Before 41+3 Weeks of Gestation (time frame: From randomization until time of birth. Assessed at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.