Sweeping the Membranes, Cervical Length and Duration of Labor

October 3, 2011 updated by: Huriye Ayse Parlakgumus

The Impact of Sweeping the Membranes on Cervical Length and Labor: A Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01110
        • Baskent Universitesi Seyhan Arastirma ve Uygulama Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • digital examination
  • bishop score

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huriye Ayse Parlakgumus

Collaborators

Baskent University

Investigators

  • Principal Investigator: Huriye A Parlakgumus, MD, Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 4, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (Estimate)

March 7, 2011

Study Record Updates

Last Update Posted (Estimate)

October 7, 2011

Last Update Submitted That Met QC Criteria

October 3, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KA 09/248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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