An observational study in Uterine Perforation, sponsored by Center for Epidemiology and Health Research, Germany. Completed at 1 site in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-17.
Sponsored by Center for Epidemiology and Health Research, Germany · Observational
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.
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 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.
Center for Epidemiology and Health Research, Germany is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Recruitment of cohort members will be conducted via a network of approximately 2000 gynecologists.
Exclusion Criteria:
Mirena®
Copper IUD
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.
Time frame: 12 months after insertion
Contraceptive Failure
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.
Time frame: Within 12 months
Overall, 63,194 patients were recruited for the EURAS-IUD study, and 1,746 patients were excluded due to protocol violations. Of these, information on the IUD inserted at baseline is missing for 859 women. Therefore, 859 recruited patients could not be assigned to one of the cohorts and are not counted in the table displaying the participant flow.
| Milestone | LNG IUS | Copper IUD |
|---|---|---|
| Started | 43600 | 18735 |
| Completed | 43078 | 18370 |
| Not completed | 522 | 365 |
| Withdrew: Protocol violation | 522 | 365 |
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.
| participants | LNG IUS | Copper IUD |
|---|---|---|
| Uterine Perforation Rate | 61 | 20 |
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.
| participants | LNG IUS | Copper IUD |
|---|---|---|
| Contraceptive Failure | 26 | 92 |
Collected over Information on adverse events was collected over a time period of 12 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LNG IUS | — | 21/43,078 (0%) | 0/43,078 (0%) |
| Copper IUD | — | 7/18,370 (0%) | 0/18,370 (0%) |
| Event | LNG IUS | Copper IUD |
|---|---|---|
| Venous thromboembolic eventCardiac disorders | 9/43078 | 5/18370 |
| Cerebrovascular EventsCardiac disorders | 9/43078 | 1/18370 |
| Myocardial infarctionCardiac disorders | 2/43078 | 1/18370 |
| Other arterial thromboembolic eventCardiac disorders | 1/43078 | 0/18370 |
| Age, Categorical(Participants) | LNG IUS | Copper IUD | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 43069 | 18370 | 61439 |
| >=65 years | 9 | 0 | 9 |
| Age, Continuous(years) | LNG IUS | Copper IUD | Total |
|---|---|---|---|
| Mean | 37.37 ± 7.54 | 33.33 ± 7.64 | 36.2 ± 7.8 |
| Sex: Female, Male(Participants) | LNG IUS | Copper IUD | Total |
|---|---|---|---|
| Female | 43078 | 18370 | 61448 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | LNG IUS | Copper IUD | Total |
|---|---|---|---|
| Germany | 16981 | 6023 | 23004 |
| Austria | 6303 | 1947 | 8250 |
| Finland | 2280 | 585 | 2865 |
| United Kingdom | 14190 | 6784 | 20974 |
| Sweden | 2693 | 2018 | 4711 |
| Poland | 631 | 1013 | 1644 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Uterine Perforation
Center for Epidemiology and Health Research, Germany