RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-20
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05254041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Between the ages of 18-45
  3. * Currently has an FDA approved IUD
  4. * Present to CWHC for IUD removal
  1. * Known sensitivity or allergy to silicone
  2. * known active vaginal infection (yeast, bacterial vaginosis, untreated sexually transmitted infection)
  3. * IUD strings not visible
  4. * Positive pregnancy test

Contacts and Locations

Study Contact

Cara Clure, MD
CONTACT
303-724-8482
cara.clure@cuanschutz.edu
Eva Dindinger, MPH
CONTACT
303-724-8482
eva.dindinger@cuanschutz.edu

Principal Investigator

Cara Clure, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Comprehensive Women's Health Center
Denver, Colorado, 80230
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Cara Clure, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-20
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-02-20
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • IUD; Complications, Mechanical
  • Menstrual Cup