National Guideline Alliance, Royal College of Obstetricians and Gynaecologists, London, UK.
Amaris Consulting, Work Life - Camden, London, UK.
Acta Obstet Gynecol Scand. 2021 Apr;100(4):727-735. doi: 10.1111/aogs.14025. Epub 2020 Nov 28.
The safety and acceptability of medical abortion using mifepristone and misoprostol at home at ≤9 weeks' gestation is well established. However, the upper gestational limit at which the procedure remains safe and acceptable at home is not known. To inform a national guideline on abortion care we conducted a systematic review to determine what gestational limit for expulsion at home offers the best balance of benefits and harms for women who are having medical abortion.
We searched Embase, MEDLINE, Cochrane Library, Cinahl Plus and Web-of-Science on 2 January 2020 for prospective and retrospective cohort studies with ≥50 women per gestational age group, published in English from 1995 onwards, that included women undergoing medical abortion and compared home expulsion of pregnancies of ≤9 weeks' gestational age with pregnancies of 9 -10 weeks or >10 weeks' gestational age, or compared the latter two gestational age groups. We assessed risk-of-bias using the Newcastle-Ottowa scale. All outcomes were meta-analyzed as risk ratios (RR) using the Mantel-Haenszel method. The certainty of the evidence was assessed using GRADE.
Six studies (n = 3381) were included. The "need for emergency care/admission to hospital" (RR = 0.79, 95% confidence interval [CI] 0.45-1.4), "hemorrhage requiring transfusion/≥500 mL blood loss" (RR = 0.62, 95% CI 0.11-3.55), patient satisfaction (RR = 0.99, 95% CI 0.95-1.03), pain (RR = 0.91, 95% CI 0.82-1.02), and "complete abortion without the need for surgical intervention" (RR = 1.03, 95% CI 1-1.05) did not differ statistically significantly between the ≤9 and >9 weeks' gestation groups. The rates of vomiting (RR = 0.8, 95% CI 0.69-0.93) and diarrhea (RR = 0.85, 95% CI 0.73-0.99) were statistically significantly lower in the ≤9 weeks group but these differences were not considered clinically important. We found no studies comparing pregnancies of 9 -10 weeks' gestation with pregnancies of >10 weeks' gestation. The certainty of this evidence was predominantly low and mainly compromised by low event rates and loss to follow up.
Women who are having a medical abortion and will be taking mifepristone up to and including 10 weeks' gestation should be offered the option of expulsion at home after they have taken the misoprostol. Further research needs to determine whether the gestational limit for home expulsion can be extended beyond 10 weeks.
米非司酮和米索前列醇用于≤9 周妊娠的在家药物流产的安全性和可接受性已得到充分证实。然而，在家中进行安全和可接受的程序的最大妊娠限制尚不清楚。为了为堕胎护理提供国家指南，我们进行了一项系统评价，以确定在家中进行妊娠排出的最大妊娠限制，为正在进行药物流产的妇女带来最佳的利益和危害平衡。
我们于 2020 年 1 月 2 日在 Embase、MEDLINE、Cochrane 图书馆、Cinahl Plus 和 Web-of-Science 上搜索了前瞻性和回顾性队列研究，这些研究包括≥50 名每个妊娠年龄组的妇女，使用英语从 1995 年开始发表，包括正在接受药物流产的妇女，并将≤9 周妊娠的妊娠与 9-10 周或>10 周妊娠的妊娠进行比较，或比较后两组妊娠年龄。我们使用纽卡斯尔-渥太华量表评估风险偏倚。所有结局均使用 Mantel-Haenszel 方法以风险比（RR）进行荟萃分析。使用 GRADE 评估证据的确定性。
共纳入 6 项研究（n=3381）。“需要紧急护理/住院”（RR=0.79，95%置信区间 [CI] 0.45-1.4）、“需要输血/≥500ml 失血量”（RR=0.62，95% CI 0.11-3.55）、患者满意度（RR=0.99，95% CI 0.95-1.03）、疼痛（RR=0.91，95% CI 0.82-1.02）和“无需手术干预即可完全流产”（RR=1.03，95% CI 1-1.05）在≤9 周和>9 周妊娠组之间无统计学差异。≤9 周组的呕吐（RR=0.8，95% CI 0.69-0.93）和腹泻（RR=0.85，95% CI 0.73-0.99）发生率统计学显著较低，但这些差异不被认为具有临床意义。我们没有发现比较 9-10 周妊娠和>10 周妊娠的研究。该证据的确定性主要为低，主要因事件发生率低和随访丢失而受到影响。
对于正在接受米非司酮治疗且将在服用米索前列醇时达到和包括 10 周妊娠的女性，应在服用米索前列醇后提供在家中进行流产的选择。需要进一步研究以确定在家中进行妊娠排出的最大妊娠限制是否可以延长至 10 周以上。
