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

This study has been withdrawn prior to enrollment.
(Difficulty recruiting patient. Lack of research assistant.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00790504
First Posted: November 13, 2008
Last Update Posted: May 2, 2017
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.
Information provided by (Responsible Party):
Dr. Vered Eisenberg, Sheba Medical Center
  Purpose
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.

Condition
Multiple Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Follow up of the Female Pelvic Floor in Multiple Gestation Using Transperineal Ultrasound

Resource links provided by NLM:


Further study details as provided by Dr. Vered Eisenberg, Sheba Medical Center:

Primary Outcome Measures:
  • Multiple gestation affects the pelvic floor more than singleton gestation [ Time Frame: Until recruitment completion ]

Secondary Outcome Measures:
  • The mode of delivery affects pelvic floor outcome [ Time Frame: As above ]

Enrollment: 0
Study Start Date: November 2008
Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with multiple gestations recruited from the prenatal care or high risk pregnancy units
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None specified
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00790504


Locations
Israel
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Vered H Eisenberg, MD MHA Sheba Medical Center
  More Information

Responsible Party: Dr. Vered Eisenberg, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00790504     History of Changes
Other Study ID Numbers: SHEBA-08-5470-VE-CTIL
First Submitted: November 11, 2008
First Posted: November 13, 2008
Last Update Posted: May 2, 2017
Last Verified: April 2017

Keywords provided by Dr. Vered Eisenberg, Sheba Medical Center:
Pelvic floor
Transperineal ultrasound
Multiple pregnancy
Singleton pregnancy
Female pelvic floor