Perforation risk and intra-uterine devices: results of the EURAS-IUD 5-year extension study

Abstract

Objectives: The objective of this analysis was to identify intra-uterine devices (IUD) perforations detected from 12 to 60 months following IUD insertion, and to combine this information with (our previously published) data about perforations detected in the first 12 months to calculate cumulative perforation rates.

Methods and materials: Prospective, non-interventional cohort study with new users of levonorgestrel-releasing intra-uterine systems (LNG-IUS) and copper-IUD. The original cohort included 61,448 women followed for 12 months. Of these, we had sufficient resources to perform an additional follow-up and analysis at 60 months in 39,009 women. Inclusion criteria for this analysis was insertion prior to 31 July 2010. All potential cases were validated via the health care professional or medical records. Crude and adjusted relative risks were calculated using a logistic regression model.

Results: We identified 23 additional perforations (19 LNG-IUS and 4 copper-IUD) more than 12 months after insertion. Added to perforations detected at 12 months, the overall perforation rate was 2.1 per 1000 insertions (95% CI: 1.6–2.8) for LNG-IUS users (40 + 19 perforations/27,630 insertions) and 1.6 per 1000 insertions (95% CI: 0.9–2.5) for copper-IUD users (14 + 4 perforations/11,379 insertions). LNG-IUS users had a borderline higher risk of perforation compared with copper-IUD users (ORadj 1.7; 95% CI: 1.0–2.8). Forty-five (58%) of the 77 perforations were associated with suspected risk factors. Breastfeeding (RR 4.9, 95% CI: 3.0–7.8) and time since delivery (RR 3.0, CI: 1.5–5.4) remained significant risk factors in perforations detected after 12 months. No perforations resulted in serious injury to intra-abdominal or pelvic structures.

Conclusions: 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.

Chinese abstract

目的：这一分析的目的是确定IUD置入12至60个月后检测到的穿孔, 并将这些信息和前12个月检测到的穿孔数据（我们之前发表过的）联系起来, 计算出累积穿孔率。

材料和方法：这是一项对左炔诺孕酮宫内缓释系统（LNG-IUS）和含铜IUD新使用者进行的前瞻性、非干预性队列研究, 最初的研究对象是61448名随访了12个月的女性。在这方面, 我们有足够的资源对39009名女性进行60个月的追加跟踪和分析。此分析的纳入标准是在2010年7月31日之前置入的女性, 所有潜在病例均经卫生保健专业人员或医疗记录确认。利用逻辑回归模型计算原始的和调整后的相对风险。

结果：在置入12个月后, 我们发现新增23例穿孔（19例 LNG-IUS和4例含铜IUD）。归入置入12个月的穿孔数, LNG-IUS使用者的总穿孔率是每1000名置入者中有2.1例穿孔（95%CI：1.6—2.8）（40 + 19例穿孔/27630例置入）；含铜IUD使用者的总穿孔率是每1000名置入者中有1.6例穿孔（95%CI：0.9—2.5）（14 + 4例穿孔/11379例置入）。与含铜IUD使用者相比, LNG-IUS使用者有一个高穿孔风险的边界线（调整比值比：1.7； 95%CI：1.0—2.8）。77例穿孔中有45例穿孔与可疑危险因素有关（58%）。母乳喂养（RR：4.9； 95%CI：3.0—7.8）和分娩后时间（RR：3.0； 95%CI：1.5—5.4）仍是置入12个月后穿孔发生的显著风险因素, 没有穿孔导致腹腔或骨盆结构的严重损伤。

结论：本研究中子宫穿孔的发生率较低, 但高于一般报告的发生率。大约三分之一的穿孔是在置入12个月后检测到的。穿孔的临床后遗症一般比较轻微, 与之相关的腹腔和骨盆结构的损伤风险很低。

注意

子宫穿孔是一种罕见的与使用宫内节育器有关的风险。虽然女性可以放心, 检测和移出宫内节育器相关穿孔发生率较低, 但穿孔的延迟诊断仍有可能出现。

Keywords:

• IUD
• breastfeeding
• prospective cohort study
• active surveillance
• levonorgestrel
• childbirth
• contraception

Disclosure statement

The study was supervised by an independent Safety Monitoring and Advisory Council with full authority over the study (including study protocol, protocol amendments, data analysis, and stopping the study).

Additional information

Funding

The study was funded by a manufacturer of hormonal contraceptives. Unconditional grant from Bayer AG, Germany. The funder had no access to the source data and did not participate in designing the study, analysing the data, or preparing this publication.