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

This study has been withdrawn prior to enrollment.
(A similar article was already published by another investigator.)
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01659528
First received: August 5, 2012
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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


Condition
Micropenis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy - A Prospective Descriptive Study.

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Penile length [ Time Frame: between 14 and 37 weeks gestation ] [ Designated as safety issue: No ]
  • Penile width [ Time Frame: between 14 and 37 weeks gestation ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women addressing for routine ultrasound scan at the ultrasound unit.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659528

Locations
Israel
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