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

Sponsor

Carmel Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01659528

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Micropenis

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy - A Prospective Descriptive Study.

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Jul 1, 2014

Outcome Measures

Primary Outcome Measures

Penile length [between 14 and 37 weeks gestation]
Penile width [between 14 and 37 weeks gestation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OBGYN Ultrasound Unit, Carmel Medical Center	Haifa		Israel

Sponsors and Collaborators

Carmel Medical Center

Investigators

Principal Investigator: Yael Goldberg, MD, Head of Obstetrics and Gynecologic Ultrasound Unit, The Lady Davis Carmel Medical Center, Affiliated with the Rappaport Faculty of Medicine, Technion, Haifa, Israel