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

NCT ID: NCT06084728

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-08-31

Brief Summary

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

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).

Conditions

Clitoris Vascularity

Study Design

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

Study Groups

Pregnant women

30 pregnant women.

Color Doppler ultrasonography

Intervention Type: DIAGNOSTIC_TEST

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

Non-pregnant women

30 non pregnant women as control group

Color Doppler ultrasonography

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Doppler

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa Seleem

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Central Contacts

Mostafa Seleem, MD

Role: CONTACT

mostafasaleem@kasralainy.edu.eg

+201001413128

Ahmed Maged, MD

Role: CONTACT

Ahmedmaged@cu.edu.eg

+201005227404

Other Identifiers

72

Identifier Type: -

Identifier Source: org_study_id