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

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ClinicalTrials.gov Identifier: NCT00790504
Recruitment Status : Withdrawn (Difficulty recruiting patient. Lack of research assistant.)
First Posted : November 13, 2008
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Vered Eisenberg, Sheba Medical Center

Brief Summary:
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 or disease
Multiple Pregnancy

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
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Follow up of the Female Pelvic Floor in Multiple Gestation Using Transperineal Ultrasound
Study Start Date : November 2008
Estimated Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

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



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

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


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

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

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 Posted: November 13, 2008    Key Record Dates
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