Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Colorado, Denver
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Female
Between the ages of 18-45
Currently has an FDA approved IUD
Present to CWHC for IUD removal
Disqualifiers
Known sensitivity or allergy to silicone
known active vaginal infection (yeast, bacterial vaginosis, untreated sexually transmitted infection)
IUD strings not visible
Positive pregnancy test
Trial design
Design model
Single group
Treatments tested in this trial
Menstrual Cup Removal
Other interventionParticipants will be asked to remove Menstrual cup by breaking the seal.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Mentrual Cup RemovalOther 1 intervention
Trial outcomes
Primary outcomes
1
The rate of IUD displacement with manufacturer-recommended menstrual cup insertion and removal
The rate of IUD displacement measured by the frequency of IUDs that shift \>1cm after manufacturer-recommended menstrual cup insertion and removal.
Time frame
12-18 monthsSecondary outcomes
1
The rate of IUD displacement measured by the frequency of IUDs that shift >1cm after manufacturer-recommended menstrual cup insertion and removal followed by insertion and removal the menstrual cup without breaking the seal.
The rate of IUD displacement measured by the frequency of IUDs that shift \>1cm after manufacturer-recommended menstrual cup insertion and removal followed by insertion and removal the menstrual cup without breaking the seal.
Time frame
12-18 monthsOther outcomes
1
III. The proportion of subjects who report pulling on the menstrual cup stem before breaking the seal.
The proportion of subjects who report pulling on the menstrual cup stem before breaking the seal.
Time frame
12-18 months2
III. The proportion of subjects who report feeling suction during menstrual cup removal.
The proportion of subjects who report feeling suction during menstrual cup removal.
Time frame
12-18 months3
III. The proportion of subjects who report palpating the IUD strings during menstrual cup removal.
The proportion of subjects who report palpating the IUD strings during menstrual cup removal.
Time frame
12-18 monthsSponsors and contacts
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Source ClinicalTrials.gov