Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
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Recruitment Status : Withdrawn (Difficulty recruiting patient.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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Israel
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Vered H Eisenberg, MD MHA Sheba Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr. Vered Eisenberg, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00790504    
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