LNG IUS vs Copper IUD: Uterine Perforation Rate
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00142 | 0.0011 | 0.00182 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00109 | 0.000705 | 0.00168 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000327 | -0.000343 | 0.000883 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.3 | 0.785 | 2.15 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.785 | 2.16 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on LNG IUS than on Copper IUD | 3,060 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | LNG IUS | New users of Mirena® IUS | 61 | 43,078 | OG000 | ClinicalTrials.gov |
| Group 2 | Copper IUD | New users of Copper IUD | 20 | 18,370 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Uterine Perforation Rate | ClinicalTrials.gov |
| Description | 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. | ClinicalTrials.gov |
| Time frame | 12 months after insertion | ClinicalTrials.gov |
| Population | Intention-to-treat (ITT) population. Number of Participants referring to the initially inserted IUS/IUD or the initial IUD insertion attempt. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | European Active Surveillance Study for Intrauterine Devices | ClinicalTrials.gov |
| NCT number | NCT00461175 | ClinicalTrials.gov |
| Phases | ClinicalTrials.gov | |
| Conditions | Uterine Perforation | ClinicalTrials.gov |
| Interventions | ClinicalTrials.gov | |
| Lead sponsor | Center for Epidemiology and Health Research, Germany | ClinicalTrials.gov |
| Results first posted | 2014-10-22 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00461175?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.