Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD

Cairo University (CU)

Status: Not yet enrolling

Conditions: Contraceptive Device; Complications

Treatments: Procedure: Office hysteroscopy; Procedure: Ultrasound guided

Study type: Interventional

Funder types: Other

Identifiers

NCT06550544

Retained IUD/Hysteroscopy/US

Details and patient eligibility

About

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.

Full 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

Enrollment: 130 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with retained IUD

Exclusion criteria

• Active pelvic infection
• Viable intrauterine pregnancy
• Cervical pathology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Office hysteroscopy

Active Comparator group

Description:

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.

Treatment:

Procedure: Office hysteroscopy

Ultrasound guided

Active Comparator group

Description:

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.

Treatment:

Procedure: Ultrasound guided