Ultrasonic Measurements of the Clitoris in Fetuses

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01011400
First received: November 10, 2009
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

Abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies. To the investigators knowledge there is no published nomogram of the clitoris size through gestation and it's assessment is usually subjective. The purpose of this study is to create a nomogram of clitorial size through gestation by measuring its size in fetuses of different age in the second and third trimester.


Condition
Ambiguous Genitalia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurements of the Fetal Clitoris by 2D Ultrasound

Further study details as provided by Meir Medical Center:

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   14 Weeks to 37 Weeks
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

pregnant women with a female fetus in the second or 3 ed trimester

Criteria

Inclusion Criteria:

  • well dated pregnancy
  • singleton pregnancy
  • female fetus
  • appropriate for gestational age

Exclusion Criteria:

  • small for gestational age
  • other fetal anomalies
  • maternal conditions that can cause exposure of the fetus to high androgen environment
  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: NCT01011400

Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01011400     History of Changes
Other Study ID Numbers: 121-09
Study First Received: November 10, 2009
Last Updated: August 27, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
clitoris

ClinicalTrials.gov processed this record on September 29, 2014