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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05702242
Enrollment
75
Registered
2023-01-27
Start date
2023-01-01
Completion date
2024-12-31
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD Removal Complication, IUD Threads Not Visible

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.

Interventions

PROCEDUREIUD removal with no visible strings

Removal with either alligator forceps or MVA

IUD removal with alligator forceps

DEVICEManual Vacuum Aspirator

IUD removal with MVA

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
First-pass IUD removal rates12-18 monthsTo compare the first-pass intrauterine device (IUD) removal rates of using manual vacuum aspiration versus alligator forceps for IUD removal with no visible strings.

Secondary

MeasureTime frameDescription
Overall IUD removal success rates12-18 monthsTo describe the overall success rates of IUD removal with no visible strings using alligator forceps versus manual vacuum aspiration.

Other

MeasureTime frameDescription
Preliminary data on satisfaction12-18 monthsTo gather preliminary data on patient and provider satisfaction.
Preliminary data on pain scores12-18 monthsTo gather preliminary data on maximum procedural pain scores measured by visual analog scale (VAS).
Preliminary data on procedure time12-18 monthsTo gather preliminary data on total procedure time.
Preliminary data on complications12-18 monthsTo gather preliminary data on complications of no strings IUD removals.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026