Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Contraceptive Device; Complications
• Intervention / Treatment: Procedure: Office hysteroscopy; Procedure: Ultrasound guided

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 Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Usama M Fouda, Prof.; Phone Number: +2 01095401375; Email: umfrfouda@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with retained IUD

Exclusion Criteria:

• Active pelvic infection
• Viable intrauterine pregnancy
• Cervical pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain	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')	Immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of IUD extraction	Percentage of successfully extracted IUD (number of extracted IUDs / total number of retained IUDs)	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Bedaya Hospital
• Investigators: Principal Investigator: Usama M Fouda, Prof., Cairo university

Publications and helpful links

General Publications

• Townsend L, Luxford E, Mizia K. Effectiveness of ultrasound-guided removal of intrauterine devices. Aust N Z J Obstet Gynaecol. 2022 Oct;62(5):800-802. doi: 10.1111/ajo.13584. Epub 2022 Jul 11.

Study record dates

Study Major Dates

• Study Start (Estimated): August 21, 2024
• Primary Completion (Estimated): February 20, 2025
• Study Completion (Estimated): February 21, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Pain; IUD; Office hysteroscopy
• Other Study ID Numbers: Retained IUD/Hysteroscopy/US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No