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临床试验/NCT02822885
NCT02822885Unknown不适用

Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding

Benha University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Uterine Artery Resistive Index According to Histological Diagnosis

研究概览

简要总结

This study was to investigate the diagnostic value of ultrasonography and blood flow measurements in uterine arteries and spiral arteries by transvaginal color Doppler ultrasonography in the detection of the endometrial pathology in women with postmenopausal bleeding.

详细描述

This prospective Cross-sectional Observational study will be conducted at the Department of Obstetrics and Gynecology, Banha University, Egypt during the period starting from January 2014. The study protocol will be approved by the Local Ethics Committee and written informed consent will be obtained from each patient before the study commenced.

Seventy patients with postmenopausal bleeding will be included in the study after verbal consent. They will be recruited from patients attending gynecologic clinic in Banha University hospital.

All patients will be subjected to the following:

For all included women the following will be done:

  1. Full history taking.
  2. Complete general, abdominal, and local examination.
  3. Ultrasonographic assessment of the uterus

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Endometrial thickness ≥ 5 mm measured by two-dimensional transvaginal ultrasound.
  • •Pap smear is negative for malignancy.

排除标准

  • •Postmenopausal woman on hormon replacement therapy.
  • •Trans-vaginal examination not possible (Vaginal stenosis or patient refusing trans-vaginal ultrasound).
  • •Adnexal pathology.
  • •General causes of bleeding e.g: Hemophilia , anticoagulation therapy

研究组 & 干预措施

ultrasonography

Experimental

Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries

干预措施: Ultrasonography (Radiation)

结局指标

主要结局

Uterine Artery Resistive Index According to Histological Diagnosis

时间窗: two weeks

The primary outcome measures is uterine artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.

Uterine Artery Pulsatility Index According to Histological Diagnosis

时间窗: 2 weeks

Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance

Endometrial Thickness According to Histological Diagnosis

时间窗: 2 weeks

Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography

Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis

时间窗: two weeks

Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance

Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis

时间窗: two weeks

The primary outcome measure is spiral artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.

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

khalid mohammed salama

MD

Benha University

研究点 (1)

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