Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD

Not Applicable

Not yet recruiting

• Conditions: Contraceptive Device; Complications
• Interventions: Procedure: Ultrasound guided; Procedure: Office hysteroscopy

• Registration Number: NCT06550544
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-04-11
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13
• Study Start: 2024-08-21
• Primary Completion: 2025-02-20
• Study Completion: 2025-02-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Patients with retained IUD

Read More

Exclusion Criteria

• Active pelvic infection
• Viable intrauterine pregnancy
• Cervical pathology

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guided	Ultrasound guided	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.
Office hysteroscopy	Office hysteroscopy	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.

Primary Outcome Measures

Name	Time	Method
Intensity of pain	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 Outcome Measures

Name	Time	Method
Success of IUD extraction	Immediately after the procedure	Percentage of successfully extracted IUD (number of extracted IUDs / total number of retained IUDs)

Trial Locations

Locations (1)

Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university; 🇪🇬 Cairo, Egypt