Clinical trial NCT05702242: A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques
Official title: A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques: Alligator Forceps Versus Manual Vacuum Aspiration (MVA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: IUD Threads Not Visible
IUD Removal Complication
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: First-pass IUD removal rates
timeFrame: 12-18 months
Secondary outcomes:
measure: Overall IUD removal success rates
timeFrame: 12-18 months
Other outcomes:
measure: Preliminary data on satisfaction
timeFrame: 12-18 months
measure: Preliminary data on pain scores
timeFrame: 12-18 months
measure: Preliminary data on procedure time
timeFrame: 12-18 months
measure: Preliminary data on complications
timeFrame: 12-18 months
Locations:
city: Denver
country: United States
facility: Comprehensive Women's Health Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Cara Clure, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wu JP, Porch E, Womack JP. Successful retrieval of an intrauterine device with "missing strings" using a manual vacuum aspirator in a desired early pregnancy: case report. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):254-6. doi: 10.1016/j.jmig.2010.11.008.
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