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

Intrauterine Device Migration Clinical Trial

— CUP-DIU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782583
• Other study ID #: HPD_2019_18
• Status: Completed
• Start date: March 18, 2020
• Est. completion date: May 17, 2021

Study information

• Verified date: June 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: May 17, 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intrauterine Device Migration
• Menstrual Cup

Intervention

Other:
• Questionnaire
questionnaire for the patients and the volontaire

Locations

Country	Name	City	State
France	cabinet IPSO	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the risk of IUD displacement in patients using menstrual cup	Transvaginal ultrasounds will be used to monitor the position of the intrauterine device in patients using a menstrual cup.	1 DAY