跳至主要内容
临床试验/NCT06550544
NCT06550544尚未招募不适用

Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD A Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
130
试验地点
1
主要终点
Intensity of pain

研究概览

简要总结

The aim of this randomized controlled study is to compare the pain experienced during extraction of retained IUD by office hysteroscopy with the pain experienced during extraction of retained IUD under ultrasound guidance . Moreover, the success of both procedures was compared. Various subgroups (patients who delivered only by Caesarean section, patients who delivered virginally, nulliparous women and menopausal patients) in both groups are compared.

详细描述

The intrauterine device (IUD) is a commonly used long-acting, effective and reversible method of contraception. The recommended way to remove a IUD is by grasping the threads with forceps and applying gentle traction until the IUD is extracted from the external os.

Absent of the threads at the time of IUD removal is reported in 4.5 to 18% of cases. If the IUD is present in the uterus and threads are not visible , its removal in the office setting can still be achieved in about 80% of patients with the use of alligator forceps or string retrieval devices, hooks or clamps. However, blind manipulation may cause uterine perforation . In cases where such devices have failed (retained IUD ), If in office extraction of IUD by these instruments failed, removal of this retained IUD in the operating room is often employed because cervical dilatation and regional or general anesthesia are needed.

In the last decade, several studies reported in office extraction of retained IUD by office hysteroscopy or under ultrasound guidance. No studies compared the efficacy or safety of these procedures

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with retained IUD

排除标准

  • Active pelvic infection
  • Viable intrauterine pregnancy
  • Cervical pathology

结局指标

主要结局

Intensity of pain

时间窗: Immediately after the procedure

Measured after the procedure using a 10 cm Visual analogue scale ( where 0 indicates no pain') and 10 indicates a 'pain as bad as it could possibly be')

次要结局

  • Success of IUD extraction(Immediately after the procedure)

研究者

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

Usama M Fouda

Prof.

Cairo University

研究点 (1)

Loading locations...

相似试验