Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782583
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2021-01-13
Brief Title:
Shifting of Intrauterine Device and Use of the Menstrual Cup Case-control Study
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Shifting of Intrauterine Device and Use of the Menstrual Cup Case-control Study
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CUP-DIU
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None