Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461175
Status:
COMPLETED
Last Update Posted:
2015-07-17
First Post:
2007-04-16
Brief Title:
European Active Surveillance Study for Intrauterine Devices
Sponsor:
Center for Epidemiology and Health Research Germany
Organization:
Center for Epidemiology and Health Research Germany
Study Overview
Official Title:
European Active Surveillance Study for Intrauterine Devices
Status:
COMPLETED
Status Verified Date:
2015-06
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:
EURAS-IUD
Brief Summary:
The primary objective of the study is to assess the risks of intrauterine device IUD use in a study population that is representative for the actual users of the individual IUDs The primary clinical outcome of interest is the uterine perforation rate
Detailed Description:
This is a large multinational prospective controlled long-term cohort study that follows a series of cohorts The cohorts consist of new users of different groups of intrauterine devices IUDs Primarily a non-interference approach - with exception of the standardized diagnostic workup to identify uterine perforations - will be used to provide standardized comprehensive and reliable information on these IUDs under routine medical conditions
The primary objective of the study is to assess the risks of intrauterine device IUD use in a study population that is representative for the actual users of the individual IUDs The primary clinical outcome of interest is the uterine perforation rate Secondary objectives are among others
the time intervals between IUD insertion and uterine perforation
impact of post-partal IUD insertion on the uterine perforation rate
proportion of uterine perforations associated with IUD insertion with serious clinical complications
the incidences of medically relevant adverse events associated with IUP use
The combined cohort will include 60000 women recruited in six European countries Enrollment should begin in November 2006 and end in 2012 Patients should undergo follow-up for at least 1 year
Recruitment of the cohort members will be conducted via a network of approximately 2000 gynecologists
Enrollment procedures should not interfere with the prescribing behavior of physicians or with the individual needs of the participating women Influence on the preference for specific oral contraceptives is to be avoided but significant efforts are to be undertaken to ensure standardized comprehensive and reliable documentation of all baseline characteristics and adverse events during the follow-up period
The study participants are women aged 18 or older who have a new insertion of an IUD and who are willing to participate in this cohort study There are no specific medical inclusion or exclusion criteria However women who are not cooperative may be excluded from study participation Also women with a language barrier will not be eligible for study inclusion
This study will maintain scientific independence and will be governed by an independent Advisory Council The Center for Epidemiology and Health Research in Berlin Germany and its research team will be accountable for the Advisory Council AC in all scientific matters The members of the AC wil be international experts in relevant scientific fields e g epidemiology gynecology and cardiology
The study started after all relevant legal and ethical requirements had been fulfilled Information on the identity of the patients and treating physicians will be kept separated from the clinical information throughout the study All relevant national data protection laws will be followed
The primary objective of the study is to assess the risks of intrauterine device IUD use in a study population that is representative for the actual users of the individual IUDs The primary clinical outcome of interest is the uterine perforation rate Secondary objectives are among others
the time intervals between IUD insertion and uterine perforation
impact of post-partal IUD insertion on the uterine perforation rate
proportion of uterine perforations associated with IUD insertion with serious clinical complications
the incidences of medically relevant adverse events associated with IUP use
The combined cohort will include 60000 women recruited in six European countries Enrollment should begin in November 2006 and end in 2012 Patients should undergo follow-up for at least 1 year
Recruitment of the cohort members will be conducted via a network of approximately 2000 gynecologists
Enrollment procedures should not interfere with the prescribing behavior of physicians or with the individual needs of the participating women Influence on the preference for specific oral contraceptives is to be avoided but significant efforts are to be undertaken to ensure standardized comprehensive and reliable documentation of all baseline characteristics and adverse events during the follow-up period
The study participants are women aged 18 or older who have a new insertion of an IUD and who are willing to participate in this cohort study There are no specific medical inclusion or exclusion criteria However women who are not cooperative may be excluded from study participation Also women with a language barrier will not be eligible for study inclusion
This study will maintain scientific independence and will be governed by an independent Advisory Council The Center for Epidemiology and Health Research in Berlin Germany and its research team will be accountable for the Advisory Council AC in all scientific matters The members of the AC wil be international experts in relevant scientific fields e g epidemiology gynecology and cardiology
The study started after all relevant legal and ethical requirements had been fulfilled Information on the identity of the patients and treating physicians will be kept separated from the clinical information throughout the study All relevant national data protection laws will be followed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None