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Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study

NCT04782583 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 740

Last updated 2021-06-22

No results posted yet for this study

Summary

In France, 26% of women of childbearing age use an intrauterine device (IUD) containing copper or levonorgestrel as a method of contraception. Failures of IUD contraception are mainly due to shifting or expulsion of the IUD. The risk factors for expulsion of IUDs most often found in the literature are young age (\<25 years), the existence of menorrhagia, dysmenorrhea, being a carrier of a copper IUD rather than a levonorgestrel IUD , a history of IUD expulsion, nulliparity, and an anomaly of the uterine cavity unrecognized (fibroma, adenomyosis).

More and more women are turning to menstrual cups (MCs) as a means of periodic protection. But the use of MC has also been mentioned as a risk factor for IUD expulsion (via a suction effect). In May 2013, reports of displacement, rupture, or even expulsion of copper IUDs in CM users were reported to ANSM.

However, few studies have examined the risks associated with the concomitant use of an MC and an IUD. The data are contradictory and insufficient to provide a clear answer to women. Hence the interest in carrying out a larger prospective study to explore the relationship between IUD expulsion and the use of MC.

Conditions

  • Menstrual Cup
  • Intrauterine Device Migration

Interventions

OTHER

Questionnaire

questionnaire for the patients and the volontaire

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2021-05-17
Completion
2021-05-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04782583 on ClinicalTrials.gov