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Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices.
Contraception. 2015 Apr; 91(4):274-9.C

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.

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.

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.

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.

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.

Authors+Show Affiliations

ZEG-Berlin, Chausseestrasse 115, 10115 Berlin, Germany. Electronic address: k.heinemann@zeg-berlin.de.ZEG-Berlin, Chausseestrasse 115, 10115 Berlin, Germany.ZEG-Berlin, Chausseestrasse 115, 10115 Berlin, Germany.ZEG-Berlin, Chausseestrasse 115, 10115 Berlin, Germany.

Pub Type(s)

Journal Article
Multicenter Study
Observational Study

Language

eng

PubMed ID

25601352

Citation

Heinemann, Klaas, et al. "Risk of Uterine Perforation With Levonorgestrel-releasing and Copper Intrauterine Devices in the European Active Surveillance Study On Intrauterine Devices." Contraception, vol. 91, no. 4, 2015, pp. 274-9.
Heinemann K, Reed S, Moehner S, et al. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015;91(4):274-9.
Heinemann, K., Reed, S., Moehner, S., & Minh, T. D. (2015). Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception, 91(4), 274-9. https://doi.org/10.1016/j.contraception.2015.01.007
Heinemann K, et al. Risk of Uterine Perforation With Levonorgestrel-releasing and Copper Intrauterine Devices in the European Active Surveillance Study On Intrauterine Devices. Contraception. 2015;91(4):274-9. PubMed PMID: 25601352.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. AU - Heinemann,Klaas, AU - Reed,Suzanne, AU - Moehner,Sabine, AU - Minh,Thai Do, Y1 - 2015/01/16/ PY - 2014/10/02/received PY - 2015/01/05/revised PY - 2015/01/08/accepted PY - 2015/1/21/entrez PY - 2015/1/21/pubmed PY - 2015/12/17/medline KW - Copper KW - Intrauterine device KW - Levonorgestrel KW - Uterine perforation SP - 274 EP - 9 JF - Contraception JO - Contraception VL - 91 IS - 4 N2 - 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. 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. 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. 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. 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. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/25601352/Risk_of_uterine_perforation_with_levonorgestrel_releasing_and_copper_intrauterine_devices_in_the_European_Active_Surveillance_Study_on_Intrauterine_Devices_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(15)00008-6 DB - PRIME DP - Unbound Medicine ER -