3D Ultrasound and Color Doppler Studies of the Clitoris in Circumcised Versus Uncircumcised Female

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT06084728
Collaborator
(none)
28
1
11.8
2.4

Study Details

Study Description

Brief Summary

Patients were divided into two groups:

Group A: 14 women with Female Circumcision that included cutting of the clitoris.

Group B: 14 women without Female Circumcision as control group.

All patients were subjected to the following:
  1. Interview with women for detailed history taking and explaining the research. A written Consent was obtained from them before their enrollment into the study.

  2. To ensure standard conditions, the subjects lied in a recumbent position and were evaluated between 08.00 and 11.00 a.m. To avoid anyexternal genital stimulation, subjects were asked not to wear trousers or cross their legs on the morning of the ultrasound examination.

  3. Furthermore, in order to minimize external effects on blood flow, all women were scanned in a noiseless room with constant heat and light

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Color Doppler ultrasonography

Detailed Description

Patients were divided into two groups:

Group A: 14 women with Female Circumcision that included cutting off the clitoris.

Group B: 14 women without Female Circumcision as a control group. Translabial ultrasound scanning was performed for each woman with Sonographic measurements of the clitoral volume and labia minora thickness performed by using a RSP-16 multi frequency transducer. The transducer was placed on the upper part of the vulva to assess the clitoris in a transverse section and on the labia majora for the sagittal view. To prevent artifacts, care was taken to avoid excessive pressure on the clitoris. The clitoris was studied where the paired corpora join in a single body that projects into the glans. Volumes were measured by reporting length, width, and depth assuming the form to be an ellipsoid: V = π/6 × D1 × D2 × D3, where D1, D2, and D3 are the maximal longitudinal, anteroposterior, and transverse diameter, respectively. The same transducer was further sagittally placed on each labium major to measure labia minora thickness, ensuring that the minimum possible pressure is applied with the ultrasound probe on the skin.

Color Doppler ultrasonography was used to identify, in a longitudinal plane, the dorsal clitoral artery, which is sampled on the outer surface of the clitoral body as previously described. With the same longitudinal approach, the terminal branch of the posterior labial artery (a branch of the internal pudendal artery) was visualized posterolaterally to the labia majora (at about 2 cm from the clitoral hood).

Study Design

Study Type:
Observational
Actual Enrollment :
28 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
3D Ultrasound and Color Doppler Studies of the Clitoris in Circumcised Versus Uncircumcised Female
Actual Study Start Date :
May 11, 2022
Actual Primary Completion Date :
Nov 18, 2022
Actual Study Completion Date :
May 4, 2023

Arms and Interventions

Arm Intervention/Treatment
Cicrumcised females

14 women with Female Circumcision that included cutting of the clitoris.

Diagnostic Test: Color Doppler ultrasonography
in a longitudinal plane, the dorsal clitoral artery, which is sampled on the outer surface of the clitoral body as previously described. With the same longitudinal approach, the terminal branch of the posterior labial artery (a branch of the internal pudendal artery) was visualized posterolaterally to the labia majora
Other Names:
  • Doppler
  • Non circumcised females

    14 women without Female Circumcision as control group

    Diagnostic Test: Color Doppler ultrasonography
    in a longitudinal plane, the dorsal clitoral artery, which is sampled on the outer surface of the clitoral body as previously described. With the same longitudinal approach, the terminal branch of the posterior labial artery (a branch of the internal pudendal artery) was visualized posterolaterally to the labia majora
    Other Names:
  • Doppler
  • Outcome Measures

    Primary Outcome Measures

    1. The peak systolic velocity of the clitoreal artery [At time of Doppler assessment]

      The peak systolic velocity of the clitoreal artery using Doppler machine to measure Blood supply to the body of clitoris in cm/second

    2. The pulsatility index of clitoreal artery [At time of Doppler assessment]

      The pulsatility index of clitoreal artery using Doppler machine to measure Blood supply to the body of clitoris in cm/second

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Both circumcised and non circumcised females between 15 and 45 years old
    Exclusion Criteria:
    • Pregnant women

    • Women with gynecological disorders

    • Genital inflammations or mases Neurological or vascular disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr Alainy medical school Cairo Egypt 12111

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed M Maged, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed M Maged, MD, professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT06084728
    Other Study ID Numbers:
    • 72
    First Posted:
    Oct 16, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 16, 2023