NCT03517696

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

May 20, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

September 18, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

April 18, 2018

Last Update Submit

September 16, 2020

Conditions

Early Labor

Outcome Measures

Primary Outcomes (1)

  • Decrease in Cesarean delivery rate

    Decrease in Cesarean delivery rate

    Up to 3 weeks

Secondary Outcomes (3)

  • Time to delivery

    Up to 3 weeks

  • Operative vaginal delivery rate

    Up to 3 weeks

  • Labor augmentation rate reduction

    Up to 3 weeks

Study Arms (2)

Membrane Sweeping

ACTIVE COMPARATOR

Membrane sweeping

Procedure: Membrane sweeping

Control

NO INTERVENTION

Routine vaginal exam

Interventions

Membrane sweepingPROCEDURE

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.

Membrane Sweeping

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Related Publications (8)

  • 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.

    PMID: 23090537BACKGROUND

  • 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.

    PMID: 19623003BACKGROUND

  • 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.

    PMID: 18984077BACKGROUND

  • 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.

    PMID: 15674873BACKGROUND

  • 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.

    PMID: 11004355BACKGROUND

  • 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.

    PMID: 16507926BACKGROUND

  • 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.

    PMID: 25082072BACKGROUND

  • 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.

    PMID: 11853301BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jeanne S Sheffield, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Intervention is not able to be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-blinded Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 7, 2018

Study Start

May 20, 2018

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

September 18, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)