Clinical trial NCT01659528: 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.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Micropenis
Keywords: Penis
Micropenis
Nomograms
Ultrasound
Fetus
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women addressing for routine ultrasound scan at the ultrasound unit.

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.

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

Primary outcomes:
measure: Penile length
timeFrame: between 14 and 37 weeks gestation
measure: Penile width
timeFrame: between 14 and 37 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: OBGYN Ultrasound Unit, Carmel Medical Center
Study officials:
affiliation: Head of Obstetrics and Gynecologic Ultrasound Unit, The Lady Davis Carmel Medical Center, Affiliated with the Rappaport Faculty of Medicine, Technion, Haifa, Israel
name: Yael Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Achiron R, Pinhas-Hamiel O, Zalel Y, Rotstein Z, Lipitz S. Development of fetal male gender: prenatal sonographic measurement of the scrotum and evaluation of testicular descent. Ultrasound Obstet Gynecol. 1998 Apr;11(4):242-5. doi: 10.1046/j.1469-0705.1998.11040242.x.
citation: Feldman KW, Smith DW. Fetal phallic growth and penile standards for newborn male infants. J Pediatr. 1975 Mar;86(3):395-8. doi: 10.1016/s0022-3476(75)80969-3.
citation: Aaronson IA. Micropenis: medical and surgical implications. J Urol. 1994 Jul;152(1):4-14. doi: 10.1016/s0022-5347(17)32804-5. No abstract available.
citation: Toppari J, Kaleva M, Virtanen HE. Trends in the incidence of cryptorchidism and hypospadias, and methodological limitations of registry-based data. Hum Reprod Update. 2001 May-Jun;7(3):282-6. doi: 10.1093/humupd/7.3.282.