Clinical Trials Directory

Trials / Completed

CompletedNCT04782583

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

Status
Completed
Phase
Study type
Observational
Enrollment
740 (actual)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERQuestionnairequestionnaire for the patients and the volontaire

Timeline

Start date
2020-03-18
Primary completion
2021-05-17
Completion
2021-05-17
First posted
2021-03-04
Last updated
2021-06-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04782583. Inclusion in this directory is not an endorsement.