Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States.
Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States.
Contraception. 2023 Oct;126:110134. doi: 10.1016/j.contraception.2023.110134. Epub 2023 Jul 29.
This study aimed to review clinical practice outcomes of early pregnancy loss (EPL) medical management using mifepristone and misoprostol outside of a clinical trial setting.
In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for EPL from May 2018 to May 2021 at our academic center-based clinic, which was a study site for a multicenter mifepristone-misoprostol EPL trial completed in March 2018. All patients received mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, with clinic follow-up typically scheduled within 1 week. The primary outcome was successful medical management, defined as management without the need for aspiration, and the secondary outcomes included additional interventions and indications, follow-up ultrasonography findings, and adverse events requiring treatment.
We treated 90 patients with a median ultrasound-measured gestational size of 49 (range 30-80) days and median time from mifepristone to misoprostol of 24 (range 8-66) hours. Follow-up was completed in clinic by 80 (88.9%), completed remotely by five (5.6%), and not completed by five (5.6%) patients. Overall, 76 (95% CI 82.9%-96.0%) of 85 patients (89.4%) with follow-up were successfully managed without uterine aspiration. Eighty patients had initial follow-up ultrasonography interpreted as gestational sac expulsion; seven (8.8%) of these ultimately underwent aspiration, including one patient who had a previously undiagnosed cesarean scar ectopic pregnancy. Two patients had significant safety outcomes: one pelvic infection and one blood transfusion during aspiration in the patient with a cesarean scar ectopic pregnancy.
Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe.
Medical management of EPL with mifepristone and misoprostol is effective and safe outside of a clinical trial setting. A standardized protocol based on the best available clinical trial evidence can be used in clinical practice for the medical management of EPL.
本研究旨在回顾米非司酮和米索前列醇在临床试验环境之外用于早期妊娠丢失（EPL）的医学管理的临床实践结果。
在这项回顾性队列研究中，我们回顾了 2018 年 5 月至 2021 年 5 月期间在我们的学术中心诊所接受米非司酮-米索前列醇治疗 EPL 的患者的匿名数据库，该诊所是 2018 年 3 月完成的多中心米非司酮-米索前列醇 EPL 试验的研究地点。所有患者均口服米非司酮 200mg，阴道或颊部给予米索前列醇 800μg，通常在 1 周内进行临床随访。主要结局是成功的医学管理，定义为无需抽吸的管理，次要结局包括其他干预措施和适应证、随访超声检查结果以及需要治疗的不良事件。
我们治疗了 90 例患者，中位超声测量妊娠大小为 49 天（范围 30-80 天），从米非司酮到米索前列醇的中位时间为 24 小时（范围 8-66 小时）。80 例（88.9%，95%置信区间 82.9%-96.0%）有随访的 85 例患者（89.4%）无需子宫抽吸即可成功管理。5 例（5.6%）患者在诊所完成随访，5 例（5.6%）患者远程完成随访，5 例（5.6%）患者未完成随访。总体而言，80 例（88.9%，95%置信区间 82.9%-96.0%）有随访的 85 例患者（89.4%）无需抽吸即可成功管理。80 例患者进行了初始随访超声检查，结果显示妊娠囊排出；其中 7 例（8.8%）最终进行了抽吸，包括 1 例先前未诊断的剖宫产瘢痕部位妊娠。2 例患者出现严重的安全结局：1 例盆腔感染，1 例剖宫产瘢痕部位妊娠患者抽吸时输血。
在临床试验环境之外，米非司酮和米索前列醇联合用于 EPL 的医学管理仍然有效且安全。可以使用基于最佳现有临床试验证据的标准化方案在临床试验之外对 EPL 进行医学管理。
在临床试验环境之外，使用米非司酮和米索前列醇进行 EPL 的医学管理是有效且安全的。可以在临床实践中使用基于最佳可用临床试验证据的标准化方案对 EPL 进行医学管理。
