Background

Reports of perforation risk related to intrauterine devices (IUDs) inserted immediately post partum and among non-post-partum individuals are scarce, and previous studies with only 12-month follow-ups underestimate the risk. Breastfeeding at IUD insertion and insertion within 36 weeks post partum have been associated with increased risk of uterine perforation. The aim of these analyses was to compare the incidence and risks of IUD-related uterine perforations by non-post-partum and post-partum intervals at IUD insertion, and among post-partum individuals, to assess the impact of breastfeeding on these outcomes.

Methods

We did a multisite cohort study in the USA, using electronic health records (EHR). Study sites were three health-care systems and a site that used data from a health-care information exchange. The study population included individuals who were aged 50 years or younger and had an IUD insertion between Jan 1, 2001, and April 30, 2018. Individuals were excluded if they had not been in the health-care system for at least 12 months before IUD insertion. The primary outcome for this analysis was any IUD-related uterine perforation diagnosis for the first IUD insertion in this time period. Both complete and partial IUD-related perforations were identified. Chart abstraction was done to validate EHR-based algorithms or confirm perforations. The crude rate and cumulative incidence of uterine perforation were evaluated by non-post-partum and post-partum intervals at IUD insertion in the full cohort, and by breastfeeding status in a subcohort of post-partum individuals. Cox models estimated crude and adjusted hazard ratios (aHRs).

Findings

Data from 326 658 individuals in the full cohort and 94 817 individuals in the post-partum subcohort were analysed. In the full cohort, we identified 1008 uterine perforations (51·2% complete), with the 5-year cumulative incidence being the lowest in the non-post-partum group (0·29%, 95% CI 0·26–0·34). The aHR for the post-partum interval relative to non-post partum ranged from 2·73 (95% CI 1·33–5·63; 0 to 3 days post partum) to 6·71 (4·80–9·38; 4 days to ≤6 weeks post partum). The post-partum subcohort of individuals with breastfeeding information had 673 uterine perforations (62% complete), with a 5-year cumulative incidence of 1·37% (95% CI 1·24–1·52) and an increased risk with breastfeeding (aHR 1·37, 95% CI 1·12–1·66).

Interpretation

Although the risk for uterine perforation with IUD insertion 4 days to 6 weeks or less post partum is nearly seven times that of insertion non-post partum, perforation remains an incredibly rare event for all clinical time points. Despite a slight increased risk of perforation with breastfeeding at IUD insertion, the benefits of breastfeeding and effective contraception generally outweigh risks and should have little clinical impact. Therefore, IUD insertion timing should be based on individual desire for IUD contraception and patient convenience to assure an IUD insertion can occur. Careful follow-up of individuals at higher risk of uterine perforation is warranted.

Funding

Bayer AG.

中文翻译：

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宫内节育器相关的子宫穿孔发生率和风险 (APEX-IUD)：一项大型多中心队列研究

背景

与产后立即置入宫内节育器 (IUD) 和非产后个体相关的穿孔风险报告很少，之前仅进行 12 个月随访的研究低估了风险。放置宫内节育器时的母乳喂养和产后 36 周内放置会增加子宫穿孔的风险。这些分析的目的是通过放置 IUD 时的非产后和产后间隔以及产后个体比较 IUD 相关子宫穿孔的发生率和风险，以评估母乳喂养对这些结果的影响。

方法

我们使用电子健康记录 (EHR) 在美国进行了一项多站点队列研究。研究地点是三个医疗保健系统和一个使用医疗保健信息交换数据的站点。研究人群包括年龄在 50 岁或以下且在 2001 年 1 月 1 日至 2018 年 4 月 30 日期间放置宫内节育器的个体。如果他们在宫内节育器之前至少 12 个月没有进入医疗保健系统，则被排除在外插入。该分析的主要结果是在此时间段内首次置入 IUD 的任何 IUD 相关子宫穿孔诊断。确定了完全和部分宫内节育器相关穿孔。进行图表抽象以验证基于 EHR 的算法或确认穿孔。子宫穿孔的粗率和累积发生率通过整个队列中宫内节育器放置的非产后和产后间隔以及产后个体子队列中的母乳喂养状态进行评估。Cox 模型估计粗略和调整后的风险比 (aHR)。

发现

分析了来自完整队列中的 326 658 名个体和产后子队列中的 94 817 名个体的数据。在整个队列中，我们确定了 1008 例子宫穿孔（51·2% 完成），5 年累积发生率在非产后组中最低（0·29%，95% CI 0·26–0 ·34). 产后间隔相对于非产后的 aHR 范围为 2·73（95% CI 1·33–5·63；产后 0 至 3 天）至 6·71（4·80–9·38 ; 产后 4 天至 ≤6 周）。有母乳喂养信息的产后子队列有 673 例子宫穿孔（62% 完成），5 年累积发生率为 1·37%（95% CI 1·24–1·52），母乳喂养的风险增加（aHR 1·37，95% CI 1·12–1·66）。

解释

尽管产后 4 天至 6 周或更短时间内放置宫内节育器的子宫穿孔风险几乎是非产后放置的七倍，但在所有临床时间点，穿孔仍然是极其罕见的事件。尽管放置宫内节育器时母乳喂养的穿孔风险略有增加，但母乳喂养和有效避孕的好处通常大于风险，并且应该对临床影响不大。因此，IUD 置入时机应根据个人对 IUD 避孕的需求和患者的便利性来确定，以确保 IUD 置入能够发生。有必要对子宫穿孔风险较高的个体进行仔细随访。

资金

拜耳公司。