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Sweeping the Membranes, Cervical Length and Duration of Labor

This study has been completed.
Sponsor:
Collaborator:
Baskent University
Information provided by (Responsible Party):
Huriye Ayse Parlakgumus, Baskent University
ClinicalTrials.gov Identifier:
NCT01309308
First received: March 4, 2011
Last updated: October 3, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention
Disorder of Amniotic Cavity and/or Membrane
 Procedure: sweeping the membranes
Other: No sweeping group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Sweeping the Membranes on Cervical Length and Labor: A Randomized Clinical Trial

Further study details as provided by Baskent University:

Primary Outcome Measures:
  • Cervical Shortening [ Time Frame: 2days ] [ Designated as safety issue: No ]
    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:
  • The Duration of Latency Until Labor [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    The period (in days) from the last cervical measurement to the start of second phase of labor.


Enrollment: 150
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309308

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

No publications provided

Responsible Party: Huriye Ayse Parlakgumus, MD, Baskent University
ClinicalTrials.gov Identifier: NCT01309308     History of Changes
Other Study ID Numbers: KA 09/248
Study First Received: March 4, 2011
Results First Received: March 18, 2011
Last Updated: October 3, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Baskent University:
cervical length
sweeping the membranes

ClinicalTrials.gov processed this record on June 18, 2013