Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06550544

Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with retained IUD

Exclusion criteria

  • Active pelvic infection
  • Viable intrauterine pregnancy
  • Cervical pathology

Treatment and study plan

Office hysteroscopy

Procedure

A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. Vaginoscopic approach will be used. A 5 F grasper will be used to grasp and extract the IUD.

Pain intensity will be assessed by visual analogue scale immediately after the procedure.

Ultrasound guided

Procedure

An alligator forceps will be introduced into the uterine cavity under ultrasound sound guidance. The IUD will be grasped and extracted outside the uterus.

Pain intensity will be assessed by visual analogue scale immediately after the procedure.

Primary outcomes

  1. Intensity of pain

    Time frame: 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')

Secondary outcomes

  1. Success of IUD extraction

    Time frame: Immediately after the procedure

    Percentage of successfully extracted IUD (number of extracted IUDs / total number of retained IUDs)

Study contacts

Contact information is provided by the study sponsor or research team.

Usama M Fouda, Prof.

CONTACT

[email protected]

01095401375 ext. +2

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Bedaya Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.