Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy

Withdrawn

• Conditions: Micropenis

• Registration Number: NCT01659528
• Lead Sponsor: Carmel Medical Center

Brief Summary

The purpose of this study is to establish nomograms of penile length and width throughout the weeks of pregnancy.

Detailed Description

Identifying pathology of male genitalia is important. It can be an isolated pathology, or connected to disorders in other organs, as part of genetic syndromes or endocrine disorders. Micropenis is a disorder, which is important to diagnose in the womb. Micropenis is defined as a penis which is measured 2.5 standard deviation below average. It is also thinner by diameter. This finding can also be the first expression of a lethal hormonal deficiency, hence the reason for early detection by ultrasound during pregnancy.

Past prenatal diagnosis ultrasound studies, measured the penis from the scrotum to the tip of the penis. Another study evaluated formalin fixated fetuses after pregnancy terminations, in which the penis was measured from the abdominal wall to the tip of the penis. To date there are no nomograms for penile length, via ultrasound measurement from abdominal wall or for penile width. The investigators assume that measuring the penis from the abdominal wall is more accurate and standard than from the end of the scrotum, which is a less definitive reference point.

The investigators aim to establish nomograms of penile length throughout the weeks of pregnancy. Exceptional penile width can also point out a problem with male genitalia. Therefore the investigators wish, as well to establish nomograms of penile width.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-05
• Study First Submitted QC: 2012-08-05
• Study First Posted: 2012-08-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Singleton pregnancy
• Proper pregnancy dating
• Normal fetal anatomical scan
• Gestational age 14 to 37 weeks
• Women aged 18 to 50

Exclusion Criteria

• Multiple pregnancy
• Gestational age under 14 or above 37 weeks
• Fetus Small or Large for gestational age
• Abnormal anatomical scan or women who didn't perform such scan
• Minors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Penile length	between 14 and 37 weeks gestation
Penile width	between 14 and 37 weeks gestation

Trial Locations

Locations (1)

OBGYN Ultrasound Unit, Carmel Medical Center; 🇮🇱 Haifa, Israel