The SWEEP Trial: a Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Membrane Stripping; Cervical Ripening; Memrane Sweeping

• Registration Number: NCT07043088
• Lead Sponsor: University of Aarhus

Brief 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 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 Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Primary Completion: 2027-08
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1536

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants with Spontaneous Onset of Labor Resulting in Birth Before 41+3 Weeks of Gestation	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

Secondary Outcome Measures

Name	Time	Method
Mode of Delivery	From onset of labor to time of birth	Spontaneous vaginal delivery; no use of vacuum or forceps. Instrumental vaginal delivery: use of vacuum or forceps. Caesarean section: scheduled or acute
Childbirth Experience	4-6 weeks postpartum	Self-reported childbirth experience measured using the validated Childbirth Experience Questionnaire (CEQ); total and subscale scores calculated.
Early Labor Experience	4-6 weeks postpartum	Self-reported early labor experience measured using the validated Early Labor Experience Questionnaire (ELEQ); total and subscale scores calculated
Undelivered at Gestational Age 41+3	From randomization until time of birth. Assessed at birth.	Still pregnant when entering the calendar date of GA 41+3 (deliveries at 41+3 counts as undelivered)
Gestational Age at Delivery	From randomization until time of birth. Assessed at birth	Length of gestation at birth in days
Randomization to Delivery Interval	From date of randomization until the date of birth, assessed up to 21 days	Hours from randomization to birth
Duration of Labor	From onset of labor (self-reported contractions or spontaneous rupture of membranes) until time of birth.	Hours from selfreported starting time of contractions or spontaneous rupture of membranes till time of birth
Duration of Active Labor	From active phase of labor to time of birth	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.
Induction Of Labor (IOL)	From date of randomization until time of birth. Assessed within 21 days.	Labor started with any induction method including AROM \<4 cm
Indication for Induction of Labor	From date of randomization until time of birth. Assessed within 21 days.	IOL due to: * Late term pregnancy (from GA 41+3-); * Maternal request; * Maternal medical indication; * Fetal indication; * Other indications
Spontaneous Rupture of Membranes	From date of randomization until time of birth. Assessed within 21 days.	Spontaneous rupture of membranes as primary labor onset occurring before contractions
Use of Oxytocin Augmentation	From active phase of labor to time of birth	Use of oxytocin augmentation during labor from more than 4 cm of cervical dilatation
Intrapartum Temperature equal to or greater than 38.0 degrees Celsius	From labor onset to time of birth	Two rectal temperature measurements of 38.0 degrees Celsius or higher, taken at least 30 minutes apart
Epidural Analgesia During Labor	From labor onset to time of birth	Administration of epidural from onset of labor till time of birth

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark