Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2025-02-21

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Contraceptive Device; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Office hysteroscopy

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Ultrasound guided

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE