The SWEEP Trial: a Randomized Controlled Trial

NCT07043088 | Recruiting DMC

• 1 other identifier: 1-10-72-82-24
• Study Type: interventional
• Target: 1,536
• Locations: 1 country
• Sites: 2

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

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; membrane stripping

Outcome Measures

Primary Outcomes (1)

• 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

  From randomization until time of birth. Assessed at birth

Secondary Outcomes (14)

• 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

Other Outcomes (27)

• Method(s) used for Labor Induction

  From date of randomization until time of birth. Assessed within 21 days.

• More than One Induction Method used

  From date of randomization until time of birth. Assessed within 21 days.

• Intrapartum Administration of Sntibiotics

  From labor onset to time of birth

Study Arms (2)

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

Procedure: Membrane sweeping

Interventions

Membrane sweeping PROCEDURE

Serial membrane sweeping from gestational age 39+5-40+2 with 2-3 days interval and a maximum og three times.

Also known as: Intervention group

Membrane sweeping

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnant women at term with a fetus in cephalic presentation and an intended vaginal delivery.

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus N, 8200, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Related Links

• The study's website

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Julie Glavind, PhD, Associate Professor, MD

  Aarhus University Hospital, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Gyrup, PhD Student

CONTACT

+4522428032; sofiegyrup@clin.au.dk

Sidsel Boie, PhD, MD, Consultant

CONTACT

+4560636835; sidselboie@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 29, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (2)