European Active Surveillance Study for Intrauterine Devices

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.