Overview

This trial is active, not recruiting.

Condition uterine perforation
Phase phase 4
Sponsor Center for Epidemiology and Health Research, Germany
Collaborator Bayer
Start date November 2006
End date June 2013
Trial size 60000 participants
Trial identifier NCT00461175, ZEG2006_01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Mirena®
Copper IUD

Primary Outcomes

Measure
Uterine perforation rate
time frame: 12 months after insertion

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - women who have a new insertion of an IUD - women who are willing to participate in this cohort study Exclusion Criteria: - women who are not cooperative - women with a language barrier

Additional Information

Official title European Active Surveillance Study for Intrauterine Devices
Principal investigator Klaas Heinemann, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Center for Epidemiology and Health Research, Germany.