Gynuity Health Projects, New York, NY, United States.
Department of Mathematics and Statistics, Elon University, Elon, NC, United States.
Contraception. 2023 Oct;126:110109. doi: 10.1016/j.contraception.2023.110109. Epub 2023 Jun 28.
This study aimed to evaluate the effectiveness and safety of medication abortion with misoprostol-only among patients treated by an abortion provider organization in the United States during the COVID-19 pandemic.
We abstracted data from patients receiving misoprostol-only for abortion from December 2020 to December 2021. Two regimens were used, both allowing three to four doses of misoprostol 800 mcg every 3 hours but differing in the recommended administration routes (vaginal, buccal, or sublingual). We estimated the proportions of patients who had complete abortion and ongoing pregnancy in the two regimen groups in complete case analyses and after imputing missing outcomes based on pretreatment characteristics. We also estimated maximum effectiveness, assuming that all patients without known treatment failures had complete abortions. We tabulated serious adverse events.
We ascertained abortion outcomes for 476 (52%) of the total 911 treated patients. Of the 476 patients, 389 (82%) had complete abortion confirmed by test or history, and 45 (9%) had ongoing pregnancies detected after the provision of treatment. These proportions did not differ significantly between the two regimen groups in adjusted complete case analyses (p > 0.44). The results of imputed analyses were similar. Of the total 911 patients, at most 90% (95% confidence interval 88%, 92%) had complete abortion, and at least 5% (95% confidence interval 4%, 7%) had ongoing pregnancy. Serious adverse events were reported in three patients (0.6% of 487 patients with data for this outcome).
Our analysis suggests that the misoprostol-only regimens studied were safe and effective for most patients. Due to high loss to follow-up, observations from patients contacted after treatment likely somewhat underestimate true effectiveness.
Medication abortion with misoprostol-only was safe and produced complete abortion in most patients with follow-up. If loss to follow-up is high, effectiveness observed by clinics may misestimate true treatment efficacy.
本研究旨在评估在 COVID-19 大流行期间,美国堕胎服务机构中使用米索前列醇进行药物流产的有效性和安全性。
我们从 2020 年 12 月至 2021 年 12 月期间接受米索前列醇单独药物流产的患者中提取数据。两种方案均允许使用三至四剂 800 mcg 米索前列醇,每 3 小时一次,但给药途径(阴道、颊部或舌下)不同。我们在完全病例分析中估计了两种方案组中完全流产和持续妊娠的患者比例,并根据预处理特征对缺失结果进行了推断。我们还根据所有无已知治疗失败的患者均完全流产的假设,估计了最大有效性。我们列出了严重不良事件。
我们确定了 911 名接受治疗的患者中 476 名(52%)的流产结局。在这 476 名患者中,389 名(82%)通过检查或病史证实完全流产,45 名(9%)在提供治疗后发现持续妊娠。在调整后的完全病例分析中,两组之间的这些比例差异无统计学意义(p>0.44)。推断分析的结果也相似。在 911 名患者中,最多 90%(95%置信区间 88%,92%)患者完全流产,至少 5%(95%置信区间 4%,7%)患者持续妊娠。在 487 名有此结局数据的患者中,有 3 名患者(0.6%)报告了严重不良事件。
我们的分析表明,研究中使用的米索前列醇单药方案对大多数患者是安全有效的。由于随访丢失率高,治疗后联系的患者观察结果可能低估了真实的有效性。
米索前列醇单独药物流产对大多数患者是安全的,能产生完全流产。如果随访丢失率高,诊所观察到的有效性可能会高估真实的治疗效果。