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

NCT ID: NCT01659528

Last Updated: 2013-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-07-31

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.

Conditions

Micropenis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yael Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Obstetrics and Gynecologic Ultrasound Unit, The Lady Davis Carmel Medical Center, Affiliated with the Rappaport Faculty of Medicine, Technion, Haifa, Israel

Locations

OBGYN Ultrasound Unit, Carmel Medical Center

Haifa, Israel, Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 9618845 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1113226 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8201683 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11392374 (View on PubMed)

Other Identifiers

CMC-11-0028-CTIL

Identifier Type: -

Identifier Source: org_study_id