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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT04782583

Collaborator

(none)

740

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Cup Intrauterine Device Migration	Other: Questionnaire

Study Design

Study Type:

Observational

Actual Enrollment :

740 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 18, 2020

Actual Primary Completion Date :

May 17, 2021

Actual Study Completion Date :

May 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
CAS	Other: Questionnaire questionnaire for the patients and the volontaire
TEMOIN	Other: Questionnaire questionnaire for the patients and the volontaire

Arm

Intervention/Treatment

CAS

Other: Questionnaire

questionnaire for the patients and the volontaire

TEMOIN

Other: Questionnaire

questionnaire for the patients and the volontaire

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	cabinet IPSO	Paris		France	75003

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04782583

Other Study ID Numbers:

HPD_2019_18

First Posted:

Mar 4, 2021

Last Update Posted:

Jun 22, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Intrauterine Device Migration

Study Results

No Results Posted as of Jun 22, 2021