N/A
Completed N=62,335
European Active Surveillance Study for Intrauterine Devices
Uterine Perforation
Source: ClinicalTrials.gov NCT00461175 ↗
Enrolled (actual)
62,335
Serious AEs
0.1%
Results posted
Oct 2014
Primary outcomePrimary: Uterine Perforation Rate — 61; 20 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uterine Perforation Rate |
61; 20 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00461175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.