IUD Removal Techniques for Intrauterine Device Removal

Recruiting in Palo Alto (17 mi)

Overseen ByCara Clure, MD

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to compare success rates of two removal techniques for intrauterine devices (IUDs) that have missing or non-visible strings. The investigators will also collect preliminary data to better understand patient and provider satisfaction, maximum pain score, procedure time, and complications with the two techniques. Participants will be randomized to IUD removal with either an alligator forceps or manual vacuum aspiration (MVA) technique. This study will provide important data on these removal techniques, which could possibly expand options for and access to no strings IUD removals.

Eligibility Criteria

This trial is for women aged 18-45 who want their IUD removed but can't see the strings. They must have a confirmed intrauterine IUD by ultrasound. Pregnant women, those with visible IUD strings, or anyone unwilling to be randomly assigned to a removal technique cannot participate.

Participant Groups

The study compares two techniques for removing IUDs without visible strings: using alligator forceps or manual vacuum aspiration (MVA). It aims to determine which method has higher success rates and gather data on patient/provider satisfaction, pain levels, time taken, and any complications.

2Treatment groups

Experimental Treatment

Group I: Removal with manual vacuum aspirationExperimental Treatment2 Interventions

Intrauterine placement of an MVA under ultrasound guidance adjacent to the IUD to remove the IUD. Multiple attempts will be performed up to a maximum of 3 unsuccessful MVA attempts, after which time, the provider will switch to the alligator forceps technique, given that this is the current standard of care.

Group II: Removal with alligator forcepsExperimental Treatment2 Interventions

Standard of care removal with passage of an intrauterine alligator forceps under ultrasound guidance to grasp and remove the IUD. If required, multiple attempts will be performed using this technique.