The SWEEP Trial: a Randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Eligibility

Primary outcome measure(s)

• Number of Participants with Spontaneous Onset of Labor Resulting in Birth Before 41+3 Weeks of Gestation — From randomization until time of birth. Assessed at birth
  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

Trial sites (2)

More University of Aarhus trials in Denmark