Uterine PerforationEURAS-IUDNCT00461175
European Active Surveillance Study for Intrauterine Devices
An observational study of Uterine Perforation, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Perforation
- How many people
- 63,194 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment of cohort members will be conducted via a network of approximately 2000 gynecologists.
Who may be able to join
- women who have a new insertion of an IUD
- women who are willing to participate in this cohort study
Who cannot join
- women who are not cooperative
- women with a language barrier
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Uterine Perforation
- Keywords
- Uterine Perforation
- Medical subject headings
- Uterine Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Mirena® | |
| 2 | Copper IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine Perforation Rate
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.
Measured: 12 months after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startNov 2006
- Primary completionMay 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63,194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany
- Investigators
- Klaas Heinemann, MD, PhD, Principal investigator, Center for Epidemiology and Health Research, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461175
- Sponsor's protocol ID
- ZEG2006_01
- Acronym
- EURAS-IUD
- Status last verified
- Jun 2015
- First submitted
- 16 Apr 2007
- Last updated
- 17 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.
PubMed 25601352Heinemann K, Reed S, Moehner S, Minh TD. Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices. Contraception. 2015 Apr;91(4):280-3. doi: 10.1016/j.contraception.2015.01.011. Epub 2015 Jan 16.
PubMed 25601350
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Active Surveillance Study for Intrauterine Devices
- ClinicalTrials.gov ID
- NCT00461175
- Acronym / sponsor ID
- EURAS-IUD / ZEG2006_01
- Conditions
- Uterine Perforation
- Keywords
- Uterine Perforation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63,194 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Nov 2006
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Apr 2007 (estimated)
- Results
- Posted 22 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Mirena® |
| 2 | – | –Copper IUD |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of cohort members will be conducted via a network of approximately 2000 gynecologists.
Key inclusion criteria (2 listed)
- women who have a new insertion of an IUD
- women who are willing to participate in this cohort study
Key exclusion criteria (2 listed)
- women who are not cooperative
- women with a language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25601352Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.
- Results publication: PubMed 25601350Heinemann K, Reed S, Moehner S, Minh TD. Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices. Contraception. 2015 Apr;91(4):280-3. doi: 10.1016/j.contraception.2015.01.011. Epub 2015 Jan 16.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaas Heinemann, MD, PhD principal investigator
Center for Epidemiology and Health Research, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Perforation, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine Perforation Rate (time frame: 12 months after insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461175, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.