A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques
NCT ID: NCT05702242
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
75 participants
INTERVENTIONAL
2023-01-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
IUD removal with no visible strings
Removal with either alligator forceps or MVA
Alligator forceps
IUD removal with alligator forceps
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.
IUD removal with no visible strings
Removal with either alligator forceps or MVA
Manual Vacuum Aspirator
IUD removal with MVA
Interventions
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IUD removal with no visible strings
Removal with either alligator forceps or MVA
Alligator forceps
IUD removal with alligator forceps
Manual Vacuum Aspirator
IUD removal with MVA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages 18 - 45 years old
* Confirmed intrauterine IUD by pelvic ultrasound
* Desires IUD removal
Exclusion Criteria
* IUD strings are visible
* Partial retained IUD (e.g. IUD arm only)
* Unwilling to be randomized to either arm
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Cara Clure, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Comprehensive Women's Health Center
Denver, Colorado, United States
Countries
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References
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Prabhakaran S, Chuang A. In-office retrieval of intrauterine contraceptive devices with missing strings. Contraception. 2011 Feb;83(2):102-6. doi: 10.1016/j.contraception.2010.07.004. Epub 2010 Aug 23. No abstract available.
Marchi NM, Castro S, Hidalgo MM, Hidalgo C, Monteiro-Dantas C, Villarroeal M, Bahamondes L. Management of missing strings in users of intrauterine contraceptives. Contraception. 2012 Oct;86(4):354-8. doi: 10.1016/j.contraception.2012.01.018. Epub 2012 Mar 27.
Verma U, Astudillo-Davalos FE, Gerkowicz SA. Safe and cost-effective ultrasound guided removal of retained intrauterine device: our experience. Contraception. 2015 Jul;92(1):77-80. doi: 10.1016/j.contraception.2015.02.008. Epub 2015 Feb 21.
Swenson C, Royer PA, Turok DK, Jacobson JC, Amaral G, Sanders JN. Removal of the LNG IUD when strings are not visible: a case series. Contraception. 2014 Sep;90(3):288-90. doi: 10.1016/j.contraception.2014.04.007. Epub 2014 Apr 21.
Mizia K, Ramsay P. The effectiveness and safety of ultrasound-guided removal of a Mirena((R)) intrauterine system when the strings are not visible and conventional office procedures have failed. Aust N Z J Obstet Gynaecol. 2013 Aug;53(4):386-8. doi: 10.1111/ajo.12103. Epub 2013 Jun 26.
da Silva Nobrega AB, Pitangui ACR, Vieira CS. Factors associated with missing strings and expulsion after postplacental insertion of copper T380A intrauterine devices. Int J Gynaecol Obstet. 2022 Apr;157(1):67-75. doi: 10.1002/ijgo.13806. Epub 2021 Jul 27.
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.
Jain A, Singh S, Elliyas S. Effectiveness of Manual Vacuum Aspiration (MVA) Device in the Management of Intrauterine Copper Devices (IUCD) with Missing Strings: A Prospective Interventional Study. J Obstet Gynaecol India. 2021 Aug;71(4):424-429. doi: 10.1007/s13224-021-01440-x. Epub 2021 Mar 15.
Guillebaud J, Kasonde JM. A simple scheme for managing the problem of 'lost threads' with intrauterine devices. Fertil Contracept. 1979 Apr;3(2):24-32.
Other Identifiers
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22-2177
Identifier Type: -
Identifier Source: org_study_id
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