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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01659528
Recruitment Status : Withdrawn (A similar article was already published by another investigator.)
First Posted : August 7, 2012
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center

Tracking Information
First Submitted Date August 5, 2012
First Posted Date August 7, 2012
Last Update Posted Date February 1, 2013
Study Start Date July 2012
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2012)
  • Penile length [ Time Frame: between 14 and 37 weeks gestation ]
  • Penile width [ Time Frame: between 14 and 37 weeks gestation ]
Original Primary Outcome Measures
 (submitted: August 5, 2012)
Penile length and width [ Time Frame: between 14 and 37 weeks gestation ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy
Official Title Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy - A Prospective Descriptive Study.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women addressing for routine ultrasound scan at the ultrasound unit.
Condition Micropenis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 31, 2013)
0
Original Estimated Enrollment
 (submitted: August 5, 2012)
250
Estimated Study Completion Date July 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01659528
Other Study ID Numbers CMC-11-0028-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Carmel Medical Center
Study Sponsor Carmel Medical Center
Collaborators Not Provided
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
PRS Account Carmel Medical Center
Verification Date January 2013