Department of Obstetrics & Gynecology, Kaiser Permanente West Los Angeles Medical Center, Los Angeles, the Department of Clinical Science and the Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, and the Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, and the Division of Research, Kaiser Permanente Northern California, Oakland, California; the Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle, Washington; RTI Health Solutions, Research Triangle Park, North Carolina; Bayer AG, Berlin, Germany; Bayer AG and Bayer OY, Espoo, Finland; Bayer Pharmaceuticals, Whippany, New Jersey, and the Department of Obstetrics and Gynecology, Indiana University School of Medicine, and the Regenstrief Institute, Indianapolis, Indiana.
Obstet Gynecol. 2023 Sep 1;142(3):641-651. doi: 10.1097/AOG.0000000000005299. Epub 2023 Aug 3.
The APEX-IUD (Association of Perforation and Expulsion of Intrauterine Devices) study evaluated the association of postpartum timing of intrauterine device (IUD) insertion, breastfeeding, heavy menstrual bleeding, and IUD type (levonorgestrel-releasing vs copper) with risks of uterine perforation and IUD expulsion in usual clinical practice. We summarize the clinically important findings to inform counseling and shared decision making.
APEX-IUD was a real-world (using U.S. health care data) retrospective cohort study of individuals aged 50 years and younger with IUD insertions between 2001 and 2018 and with electronic health record data. Cumulative incidences of uterine perforation and IUD expulsion were calculated. Adjusted hazard ratios (aHRs) and 95% CIs were estimated from proportional hazards models with control of confounding.
Among the study population of 326,658, absolute risk of uterine perforation was low overall (cumulative incidence, 0.21% [95% CI 0.19-0.23%] at 1 year and 0.61% [95% CI 0.56-0.66% at 5 years]) but was elevated for IUDs inserted during time intervals within 1 year postpartum, particularly among those between 4 days and 6 weeks postpartum (aHR 6.71, 95% CI 4.80-9.38), relative to nonpostpartum insertions. Among postpartum insertions, IUD expulsion risk was greatest for insertions in the immediate postpartum period (0-3 days after delivery) compared with nonpostpartum (aHR 5.34, 95% CI 4.47-6.39). Postpartum individuals who were breastfeeding had a slightly elevated risk of perforation and lowered risk of expulsion than those not breastfeeding. Among nonpostpartum individuals, those with a heavy menstrual bleeding diagnosis were at greater risk of expulsion than those without (aHR 2.84, 95% CI 2.66-3.03); heavy menstrual bleeding also was associated with a slightly elevated perforation risk. There was a slightly elevated perforation risk and slightly lower expulsion risk associated with levonorgestrel-releasing IUDs compared with copper IUDs.
Absolute risk of adverse outcomes with IUD insertion is low. Clinicians should be aware of the differences in risks of uterine perforation and expulsion associated with IUD insertion during specific postpartum time periods and with a heavy menstrual bleeding diagnosis. This information should be incorporated into counseling and decision making for patients considering IUD insertion.
Bayer AG.
EU PAS register, EUPAS33461.
APEX-IUD（宫内节育器穿孔和脱落协会）研究评估了产后放置宫内节育器（IUD）的时间、母乳喂养、月经过多和 IUD 类型（左炔诺孕酮释放与铜）与子宫穿孔和 IUD 脱落风险之间的关联，这些都是在常规临床实践中。我们总结了这些有临床意义的发现，以便为咨询和共同决策提供信息。
APEX-IUD 是一项真实世界（使用美国医疗保健数据）的回顾性队列研究，纳入了 2001 年至 2018 年间年龄在 50 岁及以下、有 IUD 植入史且有电子病历数据的个体。计算子宫穿孔和 IUD 脱落的累积发生率。采用比例风险模型估计调整后的危险比（aHR）和 95%CI，并控制混杂因素。
在研究人群中（326658 例），子宫穿孔的绝对风险总体较低（1 年时的累积发生率为 0.21%[95%CI 0.19-0.23%]，5 年时为 0.61%[95%CI 0.56-0.66%]），但在产后 1 年内的时间段内，IUD 插入的风险升高，尤其是产后 4 天至 6 周（aHR 6.71，95%CI 4.80-9.38）时，与非产后插入相比。在产后插入的情况下，与非产后插入相比，产后即刻（分娩后 0-3 天）的 IUD 脱落风险最高（aHR 5.34，95%CI 4.47-6.39）。与不母乳喂养的个体相比，母乳喂养的产后个体穿孔风险略有增加，而脱落风险略有降低。在非产后个体中，与无月经量大诊断的个体相比，月经过多诊断的个体脱落风险增加（aHR 2.84，95%CI 2.66-3.03）；月经过多也与穿孔风险略有增加相关。与铜 IUD 相比，释放左炔诺孕酮的 IUD 与子宫穿孔风险略有增加和脱落风险略有降低相关。
IUD 植入的不良事件绝对风险较低。临床医生应注意与特定产后时间段和月经过多诊断相关的 IUD 插入相关的子宫穿孔和脱落风险差异。这些信息应纳入考虑 IUD 植入的患者的咨询和决策中。
拜耳公司。
EUPAS33461，EU PAS 登记处。
