A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques

January 17, 2023 updated by: University of Colorado, Denver

A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques: Alligator Forceps Versus Manual Vacuum Aspiration (MVA)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intrauterine devices (IUDs) are a commonly used, highly effective form of long-acting reversible contraception in the United States. Approximately 4-18% of people with an IUD in place with have missing or non-visible IUD strings, mostly commonly due to IUD string retraction into the cervix. Currently, expert opinion suggests to remove IUDs with no visible strings using by using an alligator forceps that is placed into the uterine cavity with or without ultrasound guidance. Removal of no strings IUDs with manual vacuum aspiration (MVA) has been suggested as a possible alternative to alligator forceps. MVA is a commonly used technique for the management of miscarriage, abortion, and endometrial sampling and has potential benefits as a low cost, portable device that is readily available in family planning clinic and many office-based obstetrics and gynecology practices.

The study will compare MVA to alligator forceps for IUD removal with no visible strings. The investigators will enroll females presenting for no strings IUD removals. Potential participants will be screened for eligibility and will be excluded if they have visible IUD strings, have a positive pregnancy test, have a partially retained IUD (e.g., IUD arm only), or are unwilling to be randomized to either arm. The investigators will perform a screening pelvic exam and transvaginal ultrasound (if not already completed prior to the visit). Participants will then be randomized to one of the two removal techniques: MVA or alligator forceps. The investigators will document successful removal with the first pass of the instrument as well as successful removal with multiple attempts of the same technique. A maximum of 3 MVA removal attempts will be performed after which time, the provider will switch to using an alligator forceps as the current standard of care. Preliminary data will also be collected on patient and provider satisfaction, patient pain scores, procedure time, and complications.

This study will provide important data on MVA as a technique for IUD removals with no visible strings. No studies have compared IUD removal techniques and expanding options for removal techniques has the potential to increase access to care.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80230
        • Recruiting
        • Comprehensive Women's Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Ages 18 - 45 years old
  • Confirmed intrauterine IUD by pelvic ultrasound
  • Desires IUD removal

Exclusion Criteria:

  • Currently pregnant
  • IUD strings are visible
  • Partial retained IUD (e.g. IUD arm only)
  • Unwilling to be randomized to either arm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Removal with alligator forceps
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.
Procedure: IUD removal with no visible strings
Removal with either alligator forceps or MVA
Device: Alligator forceps
IUD removal with alligator forceps
Experimental: Removal with manual vacuum aspiration
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.
Procedure: IUD removal with no visible strings
Removal with either alligator forceps or MVA
Device: Manual Vacuum Aspirator
IUD removal with MVA
Other Names:
  • Ipas 60-mL double valve aspirator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First-pass IUD removal rates
Time Frame: 12-18 months
To compare the first-pass intrauterine device (IUD) removal rates of using manual vacuum aspiration versus alligator forceps for IUD removal with no visible strings.
12-18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall IUD removal success rates
Time Frame: 12-18 months
To describe the overall success rates of IUD removal with no visible strings using alligator forceps versus manual vacuum aspiration.
12-18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary data on satisfaction
Time Frame: 12-18 months
To gather preliminary data on patient and provider satisfaction.
12-18 months
Preliminary data on pain scores
Time Frame: 12-18 months
To gather preliminary data on maximum procedural pain scores measured by visual analog scale (VAS).
12-18 months
Preliminary data on procedure time
Time Frame: 12-18 months
To gather preliminary data on total procedure time.
12-18 months
Preliminary data on complications
Time Frame: 12-18 months
To gather preliminary data on complications of no strings IUD removals.
12-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-2177

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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