Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
NCT07043088

The SWEEP Trial: a Randomized Controlled Trial

Led by University of Aarhus · Updated on 2025-09-02

1536

Participants Needed

2

Research Sites

119 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The SWEEP Trial: a Randomized Controlled Trial

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant with a single baby at term
  • Baby positioned head first (cephalic presentation)
  • Intending to have a vaginal delivery
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Unable to speak or understand Danish
  • Gestational age not confirmed by Crown-Rump-Length measurement
  • Previous cesarean section
  • Ruptured membranes
  • Painful contractions
  • Vaginal bleeding more than bloody discharge
  • Membrane sweeping performed within the last two weeks
  • Scheduled induction of labor or known indication for induction at or before 41 weeks and 3 days gestation
  • Known low-lying placenta located less than 3 cm from the internal cervical opening verified by ultrasound

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Aarhus University Hospital

Aarhus N, Denmark, 8200

Not Yet Recruiting

2

Aarhus University Hospital

Aarhus N, Denmark, 8200

Actively Recruiting

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Research Team

S

Sofie Gyrup, PhD Student

CONTACT

S

Sidsel Boie, PhD, MD, Consultant

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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