Transperineal Ultrasound for the Female Pelvic Floor in W... | NCT00790504

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

NCT00790504

Sponsor

Sheba Medical Center

Status

Withdrawn

Last Update Posted

May 2, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Multiple Pregnancy

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty recruiting patient. Lack of research assistant.

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jan 2012Estimated

Completion Date

Jan 2012Actual

First Submitted Date

Nov 11, 2008

First Submission Date that Met QC Criteria

Nov 12, 2008

First Posted Date

Nov 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2017

Last Update Posted Date

May 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Multiple gestation affects the pelvic floor more than singleton gestation		Until recruitment completion

Secondary Outcomes

Measure	Description	Time Frame
The mode of delivery affects pelvic floor outcome		As above

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None specified

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vered H Eisenberg, MD MHA	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan		52621	Israel