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

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ClinicalTrials.gov Identifier: NCT00461175
Recruitment Status : Completed
First Posted : April 17, 2007
Results First Posted : October 22, 2014
Last Update Posted : July 17, 2015
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany

Study Description
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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.

Condition or disease
Uterine Perforation

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.


Study Design
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Study Type : Observational
Actual Enrollment : 63194 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Active Surveillance Study for Intrauterine Devices
Study Start Date : November 2006
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2013
Groups and Cohorts
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Group/Cohort
1
Mirena®
2
Copper IUD


Outcome Measures
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Primary Outcome Measures :
  1. Uterine Perforation Rate [ Time Frame: 12 months after insertion ]
    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:
  1. Contraceptive Failure [ Time Frame: Within 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications of Results:

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
First Posted: April 17, 2007    Key Record Dates
Results First Posted: October 22, 2014
Last Update Posted: July 17, 2015
Last Verified: June 2015

Keywords provided by Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany:
Uterine Perforation

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