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临床试验/NCT06084728
NCT06084728尚未招募不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
The peak systolic velocity of the clitoreal artery

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

The peak systolic velocity of the clitoreal artery

时间窗: 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

The pulsatility index of clitoreal artery

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed M Maged, MD

professor

Cairo University

研究点 (1)

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