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IUD Removal Techniques for Intrauterine Device Removal

N/A

Waitlist Available

Led By Cara Clure, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two methods of removing IUDs with missing strings and measure patient/provider satisfaction, pain, time, and complications. Results may improve access and expand options for IUD removal.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the procedures may include discomfort or pain during removal, possible injury to the uterus or cervix, bleeding, infection risk post-procedure, and emotional distress if complications occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

First-pass IUD removal rates

Secondary study objectives

Overall IUD removal success rates

Other study objectives

Preliminary data on complications

Preliminary data on pain scores

Preliminary data on procedure time

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alligator forceps

2015

N/A

~150

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