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NCT Number: NCT05702242

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Women's Health Center

Denver, Colorado, 80230, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IUD removal with no visible strings

Procedure

Removal with either alligator forceps or MVA

Alligator forceps

Device

IUD removal with alligator forceps

Manual Vacuum Aspirator

Device

IUD removal with MVA

Other names: Ipas 60-mL double valve aspirator

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Preliminary data on satisfaction

    Time frame: 12-18 months

    To gather preliminary data on patient and provider satisfaction.

  2. 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).

  3. Preliminary data on procedure time

    Time frame: 12-18 months

    To gather preliminary data on total procedure time.

  4. Preliminary data on complications

    Time frame: 12-18 months

    To gather preliminary data on complications of no strings IUD removals.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.