Transperineal Ultrasound for the Female Pelvic Floor in Women With Multiple Gestation

April 29, 2017 updated by: Dr. Vered Eisenberg, Sheba Medical Center

Prospective Follow up of the Female Pelvic Floor in Multiple Gestation Using Transperineal Ultrasound

This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses. See study protocol.

Study Type

Observational

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

  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center

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

17 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with multiple gestations recruited from the prenatal care or high risk pregnancy units

Description

Inclusion Criteria:

  • Women with multiple gestations
  • Women with singleton gestation
  • Able to understand the consent form

Exclusion Criteria:

  • None specified

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1 study group
Women with multiple gestations recruited from the prenatal care or high risk pregnancy units
2 control group
Women with singleton gestation recruited from the prenatal care or high risk pregnancy units

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Multiple gestation affects the pelvic floor more than singleton gestation
Time Frame: Until recruitment completion
Until recruitment completion

Secondary Outcome Measures

Outcome Measure
Time Frame
The mode of delivery affects pelvic floor outcome
Time Frame: As above
As above

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Vered H Eisenberg, MD MHA, Sheba Medical Center

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

November 1, 2008

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 11, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 29, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHEBA-08-5470-VE-CTIL

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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