RecruitingNot Applicable

Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use

United States80 participantsStarted 2022-02-20

Plain-language summary

This study will provide pilot data examining suction as a mechanism of IUD displacement with menstrual cup use. The investigator hypothesize that manufacturer-recommended menstrual cup insertion and removal by breaking the seal will result in 15% rate of IUD displacement/expulsion. The investigator will also use this data to explore variables associated with IUD displacement and menstrual cup use. By examining the role of suction as a possible mechanism of IUD displacement, this research will allow healthcare providers to better counsel patients who use IUDs regarding menstrual cup use. Having a better understanding of the mechanics of IUD displacement could lead to the development of strategies to prevent expulsion.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female * Between the ages of 18-45 * Currently has an FDA approved IUD * Present to CWHC for IUD removal Exclusion Criteria: * Known sensitivity or allergy to silicone * known active vaginal infection (yeast, bacterial vaginosis, untreated sexually transmitted infection) * IUD strings not visible * Positive pregnancy test

What they're measuring

The rate of IUD displacement with manufacturer-recommended menstrual cup insertion and removal

Timeframe: 12-18 months

Trial details

NCT IDNCT05254041

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Cara Clure, MD

303-724-8482 cara.clure@cuanschutz.edu

View on ClinicalTrials.gov More IUD; Complications, Mechanical trials