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

Completed

• Conditions: Menstrual Cup; Intrauterine Device Migration
• Interventions: Other: Questionnaire

• Registration Number: NCT04782583
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-18
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-04
• Primary Completion: 2021-05-17
• Study Completion: 2021-05-17
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-20
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

• Patient aged 18 or over

• Consultant for one of the following reasons:

  • IUD control
  • IUD expulsion
  • Pregnancy on IUD
  • Other reason that required an ultrasound for the IUD

• Consent to participate in the study

Exclusion Criteria

• Patient benefiting from a legal protection measure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TEMOIN	Questionnaire	-
CAS	Questionnaire	-

Primary Outcome Measures

Name	Time	Method
Evaluating the risk of IUD displacement in patients using menstrual cup	1 DAY	Transvaginal ultrasounds will be used to monitor the position of the intrauterine device in patients using a menstrual cup.

Trial Locations

Locations (1)

cabinet IPSO; 🇫🇷 Paris, France