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Membrane Sweeping in Early Labor and Delivery Outcomes

Primary Purpose

Early Labor

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Membrane sweeping
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Labor

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Membrane Sweeping

Control

Arm Description

Membrane sweeping

Routine vaginal exam

Outcomes

Primary Outcome Measures

Decrease in Cesarean delivery rate
Decrease in Cesarean delivery rate

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2018
Last Updated
September 16, 2020
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03517696
Brief Title
Membrane Sweeping in Early Labor and Delivery Outcomes
Official Title
Membrane Sweeping in Early Labor and Delivery Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study IRB approval expired
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-blinded Randomized Controlled Trial
Masking
None (Open Label)
Masking Description
Intervention is not able to be blinded
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Membrane Sweeping
Arm Type
Active Comparator
Arm Description
Membrane sweeping
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine vaginal exam
Intervention Type
Procedure
Intervention Name(s)
Membrane sweeping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease in Cesarean delivery rate
Description
Decrease in Cesarean delivery rate
Time Frame
Up to 3 weeks
Secondary Outcome Measure Information:
Title
Time to delivery
Description
Length of labor from randomization to delivery
Time Frame
Up to 3 weeks
Title
Operative vaginal delivery rate
Description
Assess a decrease in operative vaginal delivery
Time Frame
Up to 3 weeks
Title
Labor augmentation rate reduction
Description
Assess the reduction in the rate of labor augmentation ( via the use of oxytocin and/or amniotomy)
Time Frame
Up to 3 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne S Sheffield, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23090537
Citation
Spong CY, Berghella V, Wenstrom KD, Mercer BM, Saade GR. Preventing the first cesarean delivery: summary of a joint Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, and American College of Obstetricians and Gynecologists Workshop. Obstet Gynecol. 2012 Nov;120(5):1181-93. doi: 10.1097/aog.0b013e3182704880.
Results Reference
background
PubMed Identifier
19623003
Citation
ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
Results Reference
background
PubMed Identifier
18984077
Citation
Berghella V, Baxter JK, Chauhan SP. Evidence-based labor and delivery management. Am J Obstet Gynecol. 2008 Nov;199(5):445-54. doi: 10.1016/j.ajog.2008.06.093.
Results Reference
background
PubMed Identifier
15674873
Citation
Boulvain M, Stan C, Irion O. Membrane sweeping for induction of labour. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD000451. doi: 10.1002/14651858.CD000451.pub2.
Results Reference
background
PubMed Identifier
11004355
Citation
Foong LC, Vanaja K, Tan G, Chua S. Membrane sweeping in conjunction with labor induction. Obstet Gynecol. 2000 Oct;96(4):539-42. doi: 10.1016/s0029-7844(00)00995-9.
Results Reference
background
PubMed Identifier
16507926
Citation
Tan PC, Jacob R, Omar SZ. Membrane sweeping at initiation of formal labor induction: a randomized controlled trial. Obstet Gynecol. 2006 Mar;107(3):569-77. doi: 10.1097/01.AOG.0000200094.89388.70.
Results Reference
background
PubMed Identifier
25082072
Citation
Al-Harmi J, Chibber R, Fouda M, Mohammed ZK, El-Saleh E, Tasneem A. Is membrane sweeping beneficial at the initiation of labor induction? J Matern Fetal Neonatal Med. 2015 Jul;28(10):1214-8. doi: 10.3109/14767058.2014.947951. Epub 2014 Aug 18.
Results Reference
background
PubMed Identifier
11853301
Citation
Chanrachakul B, Suthutvoravut S, Sangthawan M, Herabutya Y. Effect of lower uterine segment sweeping on progress of labor in nullipara. J Med Assoc Thai. 2001 Nov;84(11):1582-6.
Results Reference
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Membrane Sweeping in Early Labor and Delivery Outcomes

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