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Sweeping the Membranes, Cervical Length and Duration of Labor

NCT ID: NCT01309308

Last Updated: 2011-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Disorder of Amniotic Cavity and/or Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

sweeping the membranes

Intervention Type PROCEDURE

The cervical length will be measured and the patient will be examined to determine the Bishop score. Later the the membranes will be swept.

No sweeping group

This group will not have sweeping of the membranes, will only have vaginal ultrasound

Group Type SHAM_COMPARATOR

No sweeping group

Intervention Type OTHER

Cervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score.

Interventions

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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.

Intervention Type PROCEDURE

No sweeping group

Cervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score.

Intervention Type OTHER

Other Intervention Names

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stripping the membranes digital examination bishop score digital examination

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role collaborator

Huriye Ayse Parlakgumus

OTHER

Sponsor Role lead

Responsible Party

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Huriye Ayse Parlakgumus

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Huriye A Parlakgumus, MD

Role: PRINCIPAL_INVESTIGATOR

Baskent University

Locations

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Baskent Universitesi Seyhan Arastirma ve Uygulama Hastanesi

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Parlakgumus HA, Yalcinkaya C, Haydardedeoglu B, Tarim E. The impact of sweeping the membranes on cervical length and labor: a randomized clinical trial. Ginekol Pol. 2014 Sep;85(9):682-7.

Reference Type DERIVED
PMID: 25322540 (View on PubMed)

Other Identifiers

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KA 09/248

Identifier Type: -

Identifier Source: org_study_id