Sweeping the Membranes, Cervical Length and Duration of Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309308
Recruitment Status : Completed
First Posted : March 7, 2011
Results First Posted : October 3, 2011
Last Update Posted : October 7, 2011
Baskent University
Information provided by (Responsible Party):
Huriye Ayse Parlakgumus, Baskent University

Brief Summary:
Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to delivery.

Condition or disease Intervention/treatment Phase
Disorder of Amniotic Cavity and/or Membrane Procedure: sweeping the membranes Other: No sweeping group Not Applicable

Detailed Description:
Cervical length will be measured in both groups. The membranes will be swept in pregnancies beyond 38 weeks by digital examination in the study group. The control group will only be examined for Bishop score. Two days later cervical length will be Measured once more.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Sweeping the Membranes on Cervical Length and Labor: A Randomized Clinical Trial
Study Start Date : February 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: The membranes swept group
This group will have a sweeping of the membranes after the 38th of gestation at hospital, in order to reduce the latency period until labor. Sweeping of the membranes is done by the insertion of examiners finger between the decidua and fetal membranes and by the circular movement of the finger, the membranes are detached from the decidua.
Procedure: sweeping the membranes
The cervical length will be measured and the patient will be examined to determine the Bishop score. Later the the membranes will be swept.
Other Names:
  • stripping the membranes
  • digital examination

Sham Comparator: No sweeping group
This group will not have sweeping of the membranes, will only have vaginal ultrasound
Other: No sweeping group
Cervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score.
Other Names:
  • bishop score
  • digital examination

Primary Outcome Measures :
  1. Cervical Shortening [ Time Frame: 2days ]
    Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.

Secondary Outcome Measures :
  1. The Duration of Latency Until Labor [ Time Frame: 15 days ]
    The period (in days) from the last cervical measurement to the start of second phase of labor.

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The patients who completed the 38th week of pregnancy, otherwise healthy gravida who have no contraindication to vaginal delivery.

Exclusion Criteria:

  • Women who have chronic disease complicating pregnancy, multiple pregnancies and in whom vaginal delivery is contraindicated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309308

Baskent Universitesi Seyhan Arastirma ve Uygulama Hastanesi
Adana, Turkey, 01110
Sponsors and Collaborators
Huriye Ayse Parlakgumus
Baskent University
Principal Investigator: Huriye A Parlakgumus, MD Baskent University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Huriye Ayse Parlakgumus, MD, Baskent University Identifier: NCT01309308     History of Changes
Other Study ID Numbers: KA 09/248
First Posted: March 7, 2011    Key Record Dates
Results First Posted: October 3, 2011
Last Update Posted: October 7, 2011
Last Verified: October 2011

Keywords provided by Huriye Ayse Parlakgumus, Baskent University:
cervical length
sweeping the membranes