Uterine Perforation
Conditions
Keywords
Uterine Perforation
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.
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.
Interventions
None listed
Sponsors
Bayer
Center for Epidemiology and Health Research, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uterine Perforation Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Contraceptive Failure | 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. |
Countries
Germany
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| LNG IUS New users of Mirena® IUS | 43,078 |
| Copper IUD New users of Copper IUD | 18,370 |
| Total | 61,448 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 522 | 365 |
Baseline characteristics
| Characteristic | LNG IUS | Copper IUD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 0 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 43069 Participants | 18370 Participants | 61439 Participants |
| Age, Continuous | 37.37 years STANDARD_DEVIATION 7.54 | 33.33 years STANDARD_DEVIATION 7.64 | 36.2 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment Austria | 6303 participants | 1947 participants | 8250 participants |
| Region of Enrollment Finland | 2280 participants | 585 participants | 2865 participants |
| Region of Enrollment Germany | 16981 participants | 6023 participants | 23004 participants |
| Region of Enrollment Poland | 631 participants | 1013 participants | 1644 participants |
| Region of Enrollment Sweden | 2693 participants | 2018 participants | 4711 participants |
| Region of Enrollment United Kingdom | 14190 participants | 6784 participants | 20974 participants |
| Sex: Female, Male Female | 43078 Participants | 18370 Participants | 61448 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43,078 | 0 / 18,370 |
| serious Total, serious adverse events | 21 / 43,078 | 7 / 18,370 |
Outcome results
Primary
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
Population: Intention-to-treat (ITT) population. Number of Participants referring to the initially inserted IUS/IUD or the initial IUD insertion attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LNG IUS | Uterine Perforation Rate | 61 participants |
| Copper IUD | Uterine Perforation Rate | 20 participants |
Comparison: The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.95% CI: [0.96, 2.7]
Comparison: The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.95% CI: [0.99, 2.78]
Other Pre-specified
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LNG IUS | Contraceptive Failure | 26 participants |
| Copper IUD | Contraceptive Failure | 92 participants |
95% CI: [0.04, 0.09]
95% CI: [0.42, 0.64]
95% CI: [0.1, 0.25]