Fetal Penile Length and Corpus Cavernosum Length - Normal... | NCT01114867

Studies
Fetal Penile Length and Corpus Cavernosum Length - Normal Measurement Via Ultrasound

NCT01114867

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Mar 27, 2014Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Fetal Penis Length

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 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 29, 2010

First Submission Date that Met QC Criteria

Apr 30, 2010

First Posted Date

May 3, 2010Estimated

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

Mar 26, 2014

Last Update Posted Date

Mar 27, 2014Estimated

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

Hypothesis: Measurement of fetal penis length by ultrasound may be inaccurate when measured from the scrotum to the penile tip. we will provide normal values of penile length measured from the penile tip to the abdominal wall and measuring the corpus cavernosum length.

Detailed Description

Not provided

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

200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women at 14th through 34th week gestation,
routine ultrasound not preformed for anomalies at the genitourinary system,
estimated fetal weight corresponds to gestational age.

Exclusion Criteria:

women who's fetuses are suspected to be with fetal growth retardation,
women who's fetuses are suspected to be with genitourinary anomaly.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Weeks

Maximum Age

34 Weeks

Standard Ages

Child

Study Population

Fetuses of healthy pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoseph Hartoov, Dr	Tel-Aviv, Soraski Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ultrasound Unit in OBGYN, Soraski Medical Center		Tel Aviv		64239	Israel