Serial membrane sweeping to encourage spontaneous labor at term
The SWEEP Trial - Serial Versus no Membrane Sweeping on Spontaneous Onset of Labor: a Randomized Controlled Trial
This trial will try serial membrane sweeping in people with low-risk, singleton pregnancies at term to see if it makes spontaneous labor happen before 41+3 weeks more often than no sweeping.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1536 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus N and 1 other locations) |
| Trial ID | NCT07043088 on ClinicalTrials.gov |
What this trial studies
The SWEEP trial is a pragmatic, open-label, multicenter randomized trial in Denmark enrolling 1,536 low-risk pregnant people with singleton, cephalic pregnancies. Participants randomized between 39+5 and 40+2 weeks will receive either no membrane sweeping or up to three membrane sweeps 2–3 days apart, performed in routine antenatal visits where possible. Data will be collected from electronic medical records and brief daily symptom questionnaires, with an additional five-week postpartum follow-up survey on birth experience. The primary outcome is spontaneous onset of labor leading to birth before gestational age 41+3 weeks.
Who should consider this trial
Good fit: Ideal candidates are people aged 18 or older with low-risk, singleton cephalic pregnancies planning vaginal birth who are between 39+5 and 40+2 weeks gestation and can speak Danish.
Not a fit: People with prior cesarean section, ruptured membranes, painful contractions, significant vaginal bleeding, scheduled induction or other indications for induction, uncertain gestational age, non‑Danish speakers, or a low‑lying placenta would not be eligible and are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this low-cost, simple procedure could increase spontaneous labor before 41+3 weeks and reduce the need for formal induction.
How similar studies have performed: Membrane sweeping is widely used and prior smaller studies and meta-analyses suggest it may modestly increase spontaneous labor, but the overall evidence is limited and of low certainty.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Aarhus N and 1 other locations
- Aarhus University Hospital — Aarhus N, Denmark (Not_yet_recruiting)
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
Study contacts
- Principal investigator: Julie Glavind, PhD, Associate Professor, MD — Aarhus University Hospital, Department of Obstetrics and Gynecology
- Study coordinator: Sofie Gyrup, PhD Student
- Email: sofiegyrup@clin.au.dk
- Phone: +4522428032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.