背景:妊娠12周后的药物流产通常需要住院。我们假设,与过夜护理程序相比,在家中施用第一次米索前列醇剂量可以增加日托程序,缩短住院时间,提高患者满意度。
方法:这个多中心,开放标签,在瑞典的6家医院进行了随机对照试验.参与者是18岁及以上的孕妇,他们在怀孕85-153天进行药物流产。随机分组为1:1,在临床上给予米非司酮,然后在家庭或医院给予第一剂米索前列醇。分配是通过打开不透明的分配信封来完成的。由于干预的性质,掩蔽是不可行的。米非司酮200mg后24-48小时,参与者在入院前2小时或住院前在家中给予米索前列醇800μg.主要结果是日托手术的比例(定义为在<9小时内完成流产)。意向治疗分析包括所有随机分配接受研究药物的参与者,以及已知主要结果的参与者。接受任何治疗的个体包括在安全性分析中。该试验在ClinicalTrials.gov注册,NTC03600857和EudraCT,2018-000964-27。
结果:在2019年1月8日至2022年12月21日之间,457名参与者被随机分配到治疗组。在意向治疗人群中,220名参与者被分配到家庭组,215名被分配到医院组。在家庭小组中,220名参与者中有156名(71%)作为日托患者完成了堕胎,与医院组215人中的99人(46%)相比(差异为24·9%,95%CI15·4-34·3;p<0·0001)。总的来说,在安全性分析中,444名参与者中有97名(22%)出现不良事件。444名参与者中有7名(2%)仅在米非司酮后流产。家庭组中220人中有2人(1%)在第一次服用米索前列醇后中止,入院前。
结论:米索前列醇的家庭管理显著增加了12孕周后药物流产中日间护理程序的比例,提供了一种安全有效的替代临床方案。
背景:VästraGötaland地区,HjalmarSvensson基金,哥德堡医学学会,斯德哥尔摩卡罗林斯卡学院地区,瑞典研究委员会。
BACKGROUND: Medical abortion after 12 gestational weeks often requires a stay in hospital. We hypothesised that administering the first misoprostol dose at home could increase day-care procedures as compared with overnight care procedures, shorten inpatient stays, and improve patient satisfaction.
METHODS: This multicentre, open-label, randomised controlled trial was done at six hospitals in Sweden. Participants were pregnant people aged 18 years and older who were undergoing medical abortion at 85-153 days of pregnancy. Randomisation was done in blocks 1:1 to
mifepristone administered in-clinic followed by home administration or hospital administration of the first dose of misoprostol. Allocation was done by opening of opaque allocation envelopes. Due to the nature of the intervention, masking was not feasible. Between 24-48 h after
mifepristone 200 mg, the participants administered 800 μg of misoprostol either at home 2 h before admission to hospital or in hospital. The primary outcome was the proportion of day-care procedures (defined as abortion completed in <9 h). The intention-to-treat analysis included all participants randomly assigned to receive the study drug and who had known results for the primary outcome. Individuals who received any treatment were included in the safety analyses. This trial is registered at ClinicalTrials.gov, NTC03600857, and EudraCT, 2018-000964-27.
RESULTS: Between Jan 8, 2019, and Dec 21, 2022, 457 participants were randomly assigned to treatment groups. In the intention-to-treat-population, 220 participants were assigned to the home group and 215 to the hospital group. In the home group, 156 (71%) of 220 participants completed the abortion as day-care patients, compared with 99 (46%) of 215 in the hospital group (difference 24·9%, 95% CI 15·4-34·3; p<0·0001). In total, 97 (22%) of 444 participants in the safety analysis had an adverse event. Seven (2%) of 444 participants aborted after
mifepristone only. Two (1%) of 220 in the home group aborted after the first dose of misoprostol, before hospital admission.
CONCLUSIONS: Home administration of misoprostol significantly increases the proportion of day-care procedures in medical abortion after 12 gestational weeks, offering a safe and effective alternative to in-clinic protocols.
BACKGROUND: Region Västra Götaland, Hjalmar Svensson\'s Fund, the Gothenburg Society of Medicine, Karolinska Institutet-Region Stockholm, and The Swedish Research Council.