RecruitingNot ApplicableNCT05254041

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


Sponsor

University of Colorado, Denver

Enrollment

80 participants

Start Date

Feb 20, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

  • Female
  • Between the ages of 18-45
  • Currently has an FDA approved IUD
  • Present to CWHC for IUD removal

Exclusion Criteria4

  • Known sensitivity or allergy to silicone
  • known active vaginal infection (yeast, bacterial vaginosis, untreated sexually transmitted infection)
  • IUD strings not visible
  • Positive pregnancy test

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Interventions

OTHERMenstrual Cup Removal

Participants will be asked to remove Menstrual cup by breaking the seal.


Locations(1)

Comprehensive Women's Health Center

Denver, Colorado, United States

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NCT05254041


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