Department of Obstetrics & Gynecology, University of Washington, Seattle, WA, USA.
RTI Health Solutions, Research Triangle Park, NC, USA.
Lancet. 2022 Jun 4;399(10341):2103-2112. doi: 10.1016/S0140-6736(22)00015-0.
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.
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).
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).
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.
Bayer AG.
关于产后即刻和非产后人群中宫内节育器（IUD）放置后穿孔风险的报告很少，并且仅有 12 个月随访的先前研究低估了风险。IUD 放置时母乳喂养和产后 36 周内放置与子宫穿孔风险增加相关。这些分析的目的是比较非产后和产后间隔时间放置 IUD 时以及产后人群中 IUD 相关子宫穿孔的发生率和风险，评估母乳喂养对这些结果的影响。
我们在美国进行了一项多地点队列研究，使用电子健康记录（EHR）。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地点。研究人群包括年龄在 50 岁及以下且在 2001 年 1 月 1 日至 2018 年 4 月 30 日期间放置 IUD 的个体。如果个体在 IUD 放置前至少 12 个月未在医疗保健系统中，则将其排除在外。该分析的主要结局是在此期间首次放置 IUD 时任何与 IUD 相关的子宫穿孔诊断。同时确定了完全和部分 IUD 相关穿孔。通过图表摘录来验证基于 EHR 的算法或确认穿孔。通过非产后和产后 IUD 放置间隔时间评估完整队列中的子宫穿孔粗率和累积发生率，并通过产后亚组中的母乳喂养状态评估子宫穿孔粗率和累积发生率。Cox 模型估计了粗率和调整后的危险比（aHR）。
在完整队列中分析了 326658 名个体的数据，在产后亚组中分析了 94817 名个体的数据。在完整队列中，我们发现了 1008 例子宫穿孔（51.2%为完全性），5 年累积发生率在非产后组最低（0.29%，95%CI 0.26-0.34）。产后间隔时间相对于非产后时间的 aHR 范围为 2.73（95%CI 1.33-5.63；产后 0-3 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亚组有 673 例子宫穿孔（62%为完全性），5 年累积发生率为 1.37%（95%CI 1.24-1.52），母乳喂养风险增加（aHR 1.37，95%CI 1.12-1.66）。
尽管产后 4 天至 6 周或更短时间内放置 IUD 导致子宫穿孔的风险接近产后非放置时间的 7 倍，但所有临床时间点的穿孔仍然是一种非常罕见的事件。尽管在放置 IUD 时母乳喂养穿孔的风险略有增加，但母乳喂养和有效避孕的益处通常超过风险，因此几乎没有临床影响。因此，IUD 放置时间应基于个人对 IUD 避孕的需求和患者的便利性，以确保可以进行 IUD 放置。需要对穿孔风险较高的个体进行仔细随访。
拜耳公司。
