Clinical trial NCT06084728: 3D Ultrasound and Color Doppler Studies of the Clitoris in Pregnant Women
Official title: 3D Ultrasound and Color Doppler Studies of the Clitoris in Pregnant Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Clitoris Vascularity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both pregnant and non pregnant women between 18 and 45 years old

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).

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

Primary outcomes:
measure: The peak systolic velocity of the clitoreal artery
timeFrame: At time of Doppler assessment
measure: The pulsatility index of clitoreal artery
timeFrame: At time of Doppler assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Cairo University
name: Mostafa Seleem
role: PRINCIPAL_INVESTIGATOR
References: