The SWEEP Trial: a Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity of Aarhus
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
< 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
Trial design
Design model
Parallel
Treatments tested in this trial
Membrane sweeping
Procedure/SurgerySerial membrane sweeping from gestational age 39+5-40+2 with 2-3 days interval and a maximum og three times.
Treatment groups
1,536 Participants
are divided into 2 treatment groupsGroup A: No membrane sweepingNo intervention 0 interventions
Group B: Membrane sweepingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Spontaneous Onset of Labor Resulting in Birth Before 41+3 Weeks of Gestation
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
Time frame
From randomization until time of birth. Assessed at birthSecondary outcomes
1
Undelivered at Gestational Age 41+3
Still pregnant when entering the calendar date of GA 41+3 (deliveries at 41+3 counts as undelivered)
Time frame
From randomization until time of birth. Assessed at birth.2
Gestational Age at Delivery
Length of gestation at birth in days
Time frame
From randomization until time of birth. Assessed at birth3
Randomization to Delivery Interval
Hours from randomization to birth
Time frame
From date of randomization until the date of birth, assessed up to 21 days4
Duration of Labor
Hours from selfreported starting time of contractions or spontaneous rupture of membranes till time of birth
Time frame
From onset of labor (self-reported contractions or spontaneous rupture of membranes) until time of birth.Other outcomes
1
Method(s) used for Labor Induction
Method(s) used for labor induction: * Prostaglandin * oxytocin \<4 cm of cervical dilatation * cervical ripening catheter * AROM
Time frame
From date of randomization until time of birth. Assessed within 21 days.2
More than One Induction Method used
Use of \>1 IOL method
Time frame
From date of randomization until time of birth. Assessed within 21 days.3
Intrapartum Administration of Sntibiotics
Any antibiotics during labor
Time frame
From labor onset to time of birth4
Endometritis Postpartum
Suspected or confirmed; requires hospital contact and antibiotics
Time frame
From time of birth to 7 days postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov