RecruitingNot ApplicableNCT07043088

The SWEEP Trial: a Randomized Controlled Trial

The SWEEP Trial - Serial Versus no Membrane Sweeping on Spontaneous Onset of Labor: a Randomized Controlled Trial


Sponsor

University of Aarhus

Enrollment

1,536 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria1

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

Exclusion Criteria10

  • < 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)

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Interventions

PROCEDUREMembrane sweeping

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


Locations(2)

Aarhus University Hospital

Aarhus N, Denmark

Aarhus University Hospital

Aarhus N, Denmark

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NCT07043088


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