Membrane Sweeping in Early Labor and Delivery Outcomes

Not Applicable

Withdrawn

• Conditions: Early Labor
• Interventions: Procedure: Membrane sweeping

• Registration Number: NCT03517696
• Lead Sponsor: Johns Hopkins University

Brief Summary

Membrane sweeping is a routine procedure in obstetrics in term patients. It has been shown to be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal delivery when used in setting of induction of labor in nulliparous patients. The goal of this study is to determine if membranes sweeping in early labor is effective in improving delivery outcomes including decreasing rate of cesarean section.

Detailed Description

This is a non-blinded randomized controlled trial. Participants will be recruited at time of presentation to triage for labor evaluation after cervical exam. Patients with a term, singleton pregnancy who present with regular, painful contractions and a Bishop score \< 7 will be recruited to the study. A random number generator will be used to create a list of random binary numbers. If the patient agrees to the study, the random number list will be used to assign the participant to membrane sweeping or no membrane sweeping. Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise. Those not assigned to membrane sweeping will not have an additional exam. Patients will then be managed as per their primary Obstetrics (OB) provider with the exception of no further membrane sweeping throughout the labor course.

Participants are only required to participate during initial evaluation and randomization. No extra study visits are required.

Due to the nature of the intervention, which requires a provider to perform a procedure, blinding will not be possible for this trial.

No therapy will be withheld for any patients. Their labor course will be managed as per their primary provider using standards of care.

Non-treatment group is necessary in order to exam the difference of effects between membrane sweeping and no membrane sweeping.

Patients will be removed from the study if they chose to withdraw their participation.

Participants will resume care as normal regardless of withdrawing study participation.

Study Timeline

• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-07
• Study Start: 2018-05-20
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-25
• Status Verified: 2020-07
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Singleton pregnancy at or after 39 weeks gestation, intact membranes, cephalic presentation, nulliparous, Bishop score <7, English or Spanish speaking

Exclusion Criteria

• Prior uterine surgery precluding vaginal delivery, maternal condition precluding vaginal delivery, fetal anomaly, prior membrane stripping

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Membrane Sweeping	Membrane sweeping	Membrane sweeping

Primary Outcome Measures

Name	Time	Method
Decrease in Cesarean delivery rate	Up to 3 weeks	Decrease in Cesarean delivery rate

Secondary Outcome Measures

Name	Time	Method
Operative vaginal delivery rate	Up to 3 weeks	Assess a decrease in operative vaginal delivery
Labor augmentation rate reduction	Up to 3 weeks	Assess the reduction in the rate of labor augmentation ( via the use of oxytocin and/or amniotomy)
Time to delivery	Up to 3 weeks	Length of labor from randomization to delivery

Trial Locations

Locations (1)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States