NCT01659528

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

August 5, 2012

Last Update Submit

January 31, 2013

Conditions

Micropenis

Keywords

PenisMicropenisNomogramsUltrasoundFetus

Outcome Measures

Primary Outcomes (2)

  • Penile length

    between 14 and 37 weeks gestation

  • Penile width

    between 14 and 37 weeks gestation

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Singleton pregnancy
  • Proper pregnancy dating
  • Normal fetal anatomical scan
  • Gestational age 14 to 37 weeks
  • Women aged 18 to 50

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OBGYN Ultrasound Unit, Carmel Medical Center

Haifa, Israel, Israel

Location

Related Publications (4)

  • 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.

    PMID: 9618845BACKGROUND

  • 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.

    PMID: 1113226BACKGROUND

  • 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.

    PMID: 8201683BACKGROUND

  • 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.

    PMID: 11392374BACKGROUND

MeSH Terms

Conditions

Penis agenesis

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2012

First Posted

August 7, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

IL(1)