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Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices.
- Source :
-
Contraception [Contraception] 2015 Apr; Vol. 91 (4), pp. 274-9. Date of Electronic Publication: 2015 Jan 16. - Publication Year :
- 2015
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Abstract
- Objectives: The objectives were to identify and compare the incidence of uterine perforation and other medically adverse events associated with levonorgestrel-releasing intrauterine systems (LNG-IUSs, releasing 20 mcg LNG daily) and copper intrauterine devices (IUDs) under routine conditions of use in a study population representative of typical users.<br />Methods and Materials: This is a multinational, prospective, non-interventional cohort study with new users of LNG-IUSs and copper IUDs. In addition to a baseline questionnaire, women and their treating health care professional completed a single follow-up questionnaire after 12 months. All patient-reported outcomes were validated by the treating physicians.<br />Results: A total of 61,448 women in six European countries were followed between 2006 and 2013 for more than 68,000 women-years of observation (70% LNG, 30% copper devices). Overall, 81 uterine perforations were reported: 61 for LNG-IUSs [1.4 per 1000 insertions (95% confidence interval {CI}: 1.1-1.8)] and 20 for copper IUDs [1.1 per 1000 insertions (95% CI: 0.7-1.7)], for an adjusted risk ratio (RRadj) of 1.6 (95% CI: 1.0-2.7) when adjusted for age, body mass index, breastfeeding at time of insertion and parity. Breastfeeding at time of insertion was associated with a sixfold increase (RR 6.1, 95% CI: 3.9-9.6), with no differences between LNG and copper IUD users. Sixty-three of the total 81 perforations were associated with previously suspected risk factors (e.g., breastfeeding, time since last delivery ≤36 weeks). No perforations led to serious illness or to injury of intra-abdominal or pelvic structures.<br />Conclusions: Uterine perforation incidence in this study was low, with a benign clinical course thereafter. The LNG-IUSs and copper IUDs did not have clinically important differences in perforation rates.<br />Implications: 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.<br /> (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adolescent
Adult
Cohort Studies
Delivery, Obstetric statistics & numerical data
Female
Humans
Intrauterine Devices, Medicated adverse effects
Middle Aged
Parity
Prospective Studies
Risk Factors
Young Adult
Breast Feeding statistics & numerical data
Contraceptive Agents, Female
Intrauterine Devices, Copper adverse effects
Levonorgestrel
Uterine Perforation etiology
Subjects
Details
- Language :
- English
- ISSN :
- 1879-0518
- Volume :
- 91
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Contraception
- Publication Type :
- Academic Journal
- Accession number :
- 25601352
- Full Text :
- https://doi.org/10.1016/j.contraception.2015.01.007