3D Ultrasound and Color Doppler Studies of the Clitoris in Pregnant Women

Patients will be divided into two groups:

Group A: 30 pregnant women Group B: 30 non pregnant women as control group.

All patients will be subjected to the following:

1. Interview with women for detailed history taking and explaining the research. A written Consent will be obtained from them before their enrollment into the study.
2. To ensure standard conditions, the subjects will lie in a recumbent position and were evaluated between 08.00 and 11.00 a.m. To avoid anyexternal genital stimulation, subjects will be 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 will be scanned in a noiseless room with constant heat and light

Study Overview

• Status: Not yet recruiting
• Conditions: Clitoris Vascularity
• Intervention / Treatment: Diagnostic test: Color Doppler ultrasonography

Detailed Description

Patients will be divided into two groups:

Group A: 30 pregnant women Group B: 30 non pregnant women as control group. Translabial ultrasound scanning will be 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 will be 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 will be 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 will be 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 will be 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) will be visualized posterolaterally to the labia majora (at about 2 cm from the clitoral hood).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Mostafa Seleem, MD; Phone Number: +201001413128; Email: mostafasaleem@kasralainy.edu.eg
• Study Contact Backup: Name: Ahmed Maged, MD; Phone Number: +201005227404; Email: Ahmedmaged@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12111
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Both pregnant and non pregnant women between 18 and 45 years old

Description

Inclusion Criteria:

• Both pregnant and non pregnant women between 18 and 45 years old

Exclusion Criteria:

• Women with genital anomalies
• Virgins
• Women with gynecological disorders as endometriosis or pelvic pathology causing pelvic congestion
• Genital inflammations or mases Neurological or vascular disorders

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women; 30 pregnant women.	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-pregnant women; 30 non pregnant women 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The peak systolic velocity of the clitoreal artery	The peak systolic velocity of the clitoreal artery using Doppler machine to measure Blood supply to the body of clitoris in cm/second	At time of Doppler assessment
The pulsatility index of clitoreal artery	The pulsatility index of clitoreal artery using Doppler machine to measure Blood supply to the body of clitoris in cm/second	At time of Doppler assessment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mostafa Seleem, Cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: October 1, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 72

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No