Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Lukyanova Institute of Pediatrics, Obstetrics and Gynecology, National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine.
Acta Obstet Gynecol Scand. 2023 May;102(5):541-548. doi: 10.1111/aogs.14549. Epub 2023 Mar 18.
The administration of mifepristone, followed by misoprostol, is widely used for medical abortion. Many studies have demonstrated home abortion to be safe in pregnancies up to 63 days of gestation, and recent data support its safety when extended to more advanced pregnancies. We studied the efficacy and acceptability of home use of misoprostol up to 70 days of gestation in a Swedish setting and compared the outcomes between pregnancies with a gestational age of up to 63 days and pregnancies with gestational age 64-70 days.
This prospective cohort study was performed between November 2014 and November 2021 at Södersjukhuset and Karolinska University Hospital, Stockholm, and some patients were also recruited from Sahlgrenska University Hospital, Göteborg and Helsingborg Hospital. The primary outcome was the rate of complete abortions and was defined as complete abortion without any need for surgical or medical intervention and assessed by clinical assessment, pregnancy test and/or vaginal ultrasound. Secondary objectives were assessed by daily self-reporting in a diary and included pain, bleeding, side effects and women's satisfaction and perception of home use of misoprostol. A comparison of categorical variables was made with Fisher's exact test. The significance level was set to a p-value ≤0.05. The study was registered at Clinicaltrials.gov on July 14, 2014 (NCT02191774).
During the study period we enrolled 273 women opting for medical abortion with home use of misoprostol. In the early group, up to 63 days of gestation, 112 women were included with a mean gestational length of 45 days and in the late group, 64-70 days of gestation, 161 women with a mean gestations length of 66.3 days were included. Complete abortion occurred in 95% (95% CI 89-98) of women in the early group and in 96% (95% CI 92-99) in the late group. No differences were found regarding side effects and acceptability was similarly high in both groups.
Our results show high efficacy and acceptability of medical abortion when misoprostol is administered at home up to 70 days of gestation. This supports previous findings about maintained safety when misoprostol is administered at home even past a very early pregnancy.
米非司酮联合米索前列醇广泛用于药物流产。许多研究已经证明，在怀孕 63 天内进行家庭流产是安全的，最近的数据支持将其安全性扩展到更晚期的妊娠。我们在瑞典研究了米索前列醇在家中使用至 70 天的有效性和可接受性，并比较了妊娠龄 63 天内和妊娠龄 64-70 天的妊娠结局。
这项前瞻性队列研究于 2014 年 11 月至 2021 年 11 月在 Södersjukhuset 和 Karolinska 大学医院进行，一些患者也在哥德堡 Sahlgrenska 大学医院和赫尔辛堡医院招募。主要结局是完全流产率，定义为无需手术或医疗干预即可完全流产，并通过临床评估、妊娠试验和/或阴道超声进行评估。次要目标通过日记中的每日自我报告进行评估，包括疼痛、出血、副作用以及女性对在家使用米索前列醇的满意度和看法。用 Fisher 确切检验比较分类变量。显著性水平设定为 p 值≤0.05。该研究于 2014 年 7 月 14 日在 Clinicaltrials.gov 注册（NCT02191774）。
在研究期间，我们招募了 273 名选择在家中使用米索前列醇进行药物流产的女性。在早期组（63 天内），包括 112 名平均妊娠 45 天的女性，在晚期组（64-70 天），包括 161 名平均妊娠 66.3 天的女性。早期组完全流产率为 95%（95%CI 89-98），晚期组为 96%（95%CI 92-99）。两组的副作用无差异，可接受性相似。
我们的结果表明，在家中使用米索前列醇至 70 天的妊娠，药物流产的有效性和可接受性很高。这支持了之前关于在家中使用米索前列醇即使在早期妊娠后仍保持安全性的发现。
