European Active Surveillance Study for Intrauterine Devices (EURAS-IUD)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00461175
First received: April 16, 2007
Last updated: June 24, 2015
Last verified: June 2015
  Purpose

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.


Condition Phase
Uterine Perforation
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Active Surveillance Study for Intrauterine Devices

Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:
  • Uterine Perforation Rate [ Time Frame: 12 months after insertion ] [ Designated as safety issue: Yes ]
    Uterine perforation is a potentially serious complication of intrauterine device (IUD) use. The absolute risk of uterine perforation associated with the LNG IUS in routine medical practice has not hitherto been well defined. It is also unknown whether the perforation rate is higher with this IUD than with copper IUDs.


Other Outcome Measures:
  • Contraceptive Failure [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
    Intrauterine contraceptive methods have low Pearl Indices. Nevertheless, there is a lack of comparative data between LNG IUS users and copper IUD users. Women with unintended pregnancies were explicitly aked whether the pregnancy occured despite IUD use. The 29 pregnancies that occured after unrecognized IUD expulsion were considered to have resulted from a failure of the contraceptive method and were therefore included in the analysis.


Enrollment: 63194
Study Start Date: November 2006
Study Completion Date: December 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Mirena®
2
Copper IUD

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Recruitment of cohort members will be conducted via a network of approximately 2000 gynecologists.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461175

Locations
Germany
Center for Epidemiology and Health Research
Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
Principal Investigator: Klaas Heinemann, MD, PhD Center for Epidemiology and Health Research, Germany
  More Information

Publications:
Responsible Party: Klaas Heinemann, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00461175     History of Changes
Other Study ID Numbers: ZEG2006_01
Study First Received: April 16, 2007
Results First Received: October 16, 2014
Last Updated: June 24, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Center for Epidemiology and Health Research, Germany:
Uterine Perforation

Additional relevant MeSH terms:
Uterine Perforation
Genital Diseases, Female
Rupture
Uterine Diseases
Uterine Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on July 30, 2015