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

This study is not yet open for participant recruitment.

Verified by Sheba Medical Center, November 2008

First Received: November 11, 2008 Last Updated: November 12, 2008 History of Changes

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00790504

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:	Cohort, Prospective
Official Title:	Prospective Follow up of the Female Pelvic Floor in Multiple Gestation Using Transperineal Ultrasound

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems Ultrasound

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

Multiple gestation affects the pelvic floor more than singleton gestation [ Time Frame: Until recruitment completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The mode of delivery affects pelvic floor outcome [ Time Frame: As above ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	November 2008

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

Eligibility

Ages Eligible for Study:	17 Years to 60 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790504

Contacts

Contact: Vered H Eisenberg, MD, MHA

972-52-3289053

veredeis@bezeqint.net

Locations

Israel
Sheba Medical Center
Ramat Gan, Israel, 52621

Sponsors and Collaborators

Sheba Medical Center

More Information

No publications provided

Responsible Party:	Sheba Medical Center ( Dr. Vered Eisenberg )
Study ID Numbers:	SHEBA-08-5470-VE-CTIL
Study First Received:	November 11, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00790504 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Sheba Medical Center:

Pelvic floor
Transperineal ultrasound
Multiple pregnancy
Singleton pregnancy
Female pelvic floor

ClinicalTrials.gov processed this record on September 10, 2009