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临床试验/NCT01541241
NCT01541241已完成不适用

Uterine Haemodynamic Changes in Patients With Copper Intrauterine Device Induced Bleeding

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1

研究概览

简要总结

THE AIM OF THE this study is to assess the hemodynamic changes of uterine artery in patients with CIUD induced bleeding by using transvaginal color Doppler indices (uterine artery resistance index and pulsatility index) to prove the relationship between these changes and bleeding in these patient .

详细描述

Intrauterine contraceptive device (IUD) is one of the most frequently used methods of birth control around the world. IUD induced irregular uterine bleeding is one of the main problems for many women using this method. In the first year of insertion of the IUDs, between 5 to 15% of women will have their IUDs removed because of bleeding. The use of IUD has been unfortunately associated with functional failure on one hand, and medical complications on the other hand. Despite the increasing use of intrauterine device, their further dissemination has been limited by high expulsion rates and the withdrawal of their use for medical reasons, mainly bleeding and pain.

Following insertion of modern copper IUD, menstrual blood loss increases by about 55%, and this level of bleeding continues for the duration of IUD use. These changes occur more rapidly, and iron supplementation is recommended.

There are several possible mechanisms that explain the cause of excessive bleeding in patients using IUD. Several studies reported that IUD insertion increase the production of prostaglandins in the endometrium which cause increased vascularity, vascular permeability, and inhibit platelet activity and therefore increase menstrual bleeding.

Recent studies have reported that IUD causes cyclo-oxygenase-2 (COX-2) up expression, the subsequent elevated prostanoid biosynthesis and signaling can promote the expression of pro-angiogenic factors, such as vascular endothelial growth factor (VEGF) , basic fibroblast growth factor (bFGF), platelet derived growth factor (PDGF), angioprotein-1 (Ang-1) and angioprotein-2 (Ang-2) or down-regulate the expression of anti-angiogenic genes such as cathepsin-D.

There are several mechanisms explaining the association of the pulsatility index (PI) and resistance index (RI) of uterine artery with menstrual blood loss. It has been suggested that menorrhagia, may be caused by an increased uterine secretion of prostanoids leading to impaired haemostasis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Regularly menstruating women before CIUD insertion.
  • Age between 18 and 35 years.
  • Hormonal treatment has not been taken at least two months before the study.
  • Non steroidal anti-inflammatory drugs has not been taken 24 hours before the examination.

排除标准

  • The presence of pelvic pathology as ovarian cysts, pelvic endometriosis, endometrial polyps or fibrosis.
  • Present or past history of pelvic inflammatory disease.
  • Patients on hormonal treatment in the last two months before the study.
  • Patients on non steroidal anti-inflammatory drugs last 24 hours before the examination.

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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