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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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IUD Threads Not Visible, IUD Removal Complication

Intervention / Treatment
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* Procedure: IUD removal with no visible strings
* Device: Alligator forceps
* Device: Manual Vacuum Aspirator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Removal with alligator forceps<br>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<br>* Removal with either alligator forceps or MVA<br>Device: Alligator forceps<br>* IUD removal with alligator forceps<br>|
| Experimental: Removal with manual vacuum aspiration<br>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<br>* Removal with either alligator forceps or MVA<br>Device: Manual Vacuum Aspirator<br>* IUD removal with MVA<br>* Other names: Ipas 60-mL double valve aspirator;|

What is the study measuring?
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Primary Outcome Measures

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