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The SWEEP Trial: a Randomized Controlled Trial

NCT07043088 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1536

Last updated 2025-09-02

No results posted yet for this study

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

Interventions

PROCEDURE

Membrane sweeping

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Julie Glavind, PhD, Associate Professor, MD · Aarhus University Hospital, Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2027-08-31
Completion
2027-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043088 on ClinicalTrials.gov