NCT00790504

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

3.2 years

First QC Date

November 11, 2008

Last Update Submit

April 29, 2017

Conditions

Multiple Pregnancy

Keywords

Pelvic floorTransperineal ultrasoundMultiple pregnancySingleton pregnancyFemale pelvic floor

Outcome Measures

Primary Outcomes (1)

  • Multiple gestation affects the pelvic floor more than singleton gestation

    Until recruitment completion

Secondary Outcomes (1)

  • The mode of delivery affects pelvic floor outcome

    As above

Study Arms (2)

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 Criteria

Age17 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Study Officials

  • Vered H Eisenberg, MD MHA

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

November 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

IL(1)