The European Active Surveillance Study on Intrauterine Devices is the first large-scale, prospective, non-interventional study to compare the perforation risk in LNG-IUS and copper IUD users. It is the first to examine the independent roles that breastfeeding status and postpartum status have on perforation risk. Conducted during routine clinical practice, the findings are generalizable to broader populations.

To our knowledge, this is the first large-scale, multinational, prospective epidemiological study to measure and compare the contraceptive effectiveness of LNG IUSs and copper IUDs during routine clinical practice. Clinicians and patients should be aware of differences in rates of unintended pregnancies and associated complications in relation to IUD us.

The incidence of uterine perforations in this study was low, although higher than the commonly reported rate. Approximately one third of perforations are detected 12 months after insertion. Clinical sequalae of perforations are generally mild and associated with a very low risk of injury to intra-abdominal and pelvic structures. Implications Uterine perforation is a rare risk associated with intra-uterine device use. Late diagnosed perforations can occur, although women can be reassured that the morbidity associated with detection and removal is low.

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Zusammenfassung Zielstellung: In der Literatur wurde konsistent bei Nutzung oraler Contraceptiva (OCs) ein reduziertes Risiko von Uterus-und Ovarialtumoren berichtet. Der Effekt von niedrigdosierten OCs ist weniger klar. Methodik: Die Deutsche Kohortenstudie zur Frauengesundheit erfasst von Frauen aller Bundesländer, die sich zur Teilnahme bereit erklärt haben, selbst berichtete Daten zur Hormonnutzung. Diese Daten umfassen Angaben zu Zeit, Typ, Dosis der Exposition wie auch zur Zeit des Auftritts von Erkrankungen. Die ersten Kohortendaten von 1998 bis 2000 wurden mittels logistischer Regression analysiert, um den Zusammenhang zwischen lebenslanger OC-Nutzung und dem Auftreten von Uterus-und Ovarialtumoren zu analysieren. Ergebnisse: Die Frauenkohorte enthält gegenwärtig rund 396 000 Frauenbeobachtungsjahre von rund 10 000 Teilnehmerinnen mit 167 malignen sowie 1676 benignen Tumoren. Das adjustierte relative Risiko [RR] des Auftretens von Uterus-oder Ovarialkrebs bei OC-Nutzern verglichen mit Nienutzern war 0,5 (95% Konfidenzintervall [95 % CI]: 0,3 ± 0,7). Der Vergleich von Nutzern niedrigdosierter OCs mit Nienutzern ergab ein adjustiertes RR von 0,1 [95 % CI 0,1 ± 0,3]). Vergleichbare Ergebnisse wurden bei benignen Tumoren der primären Reproduktionsor- AbstractObjective: The literature consistently showed a decreased risk of uterine and ovarian tumours in users of oral contraceptives (OCs). The effect of OCs with low estrogen content is less clear. Methods: The German Cohort Study on Womens Health collects self-reported data on hormone use from women who responded to a call for participation circulated in all German states. The data include information on the exposure and time, type and dose of exposure as well as time of occurrence of any outcome. Initial cohort data from 1998 to 2000 were analysed using logistic regression to determine the association between historic OC use and the occurrence of tumours of the ovary and corpus uteri. Results: The cohort currently covers about 396 000 womenyears of observation on 10 000 participants including 167 cases of malignant and 1676 cases of benign uterine and ovarian tumours. The adjusted relative risk [RR] for the occurrence of any uterine or ovarian cancer comparing users and non-users of OCs is 0.5 (95% confidence interval [95 %CI]: 0.3 to 0.7). The comparison of users of low estrogen-dose OCs versus never-users shows an adjusted RR of 0.1 [95 % CI 0.1 to 0.3]). Similar results are found for benign tumours of the primary reproductive organs. Time since last OC use was an important effect modifier in malignant, but not in benign tumours. Originalarbeit 566Institutsangaben