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Last reviewed: October 18, 2022
Recommendation:
- Mifepristone can be taken in a facility or at home.
- Home use of misoprostol following mifepristone or in a misoprostol-only regimen may be offered up to 12 weeks gestation.
- After 12 weeks gestation, misoprostol should be used in a facility.
Strength of recommendation: Strong
Quality of evidence:
- Up to 70 days gestation: Moderate
- Over 70 days gestation: Very low
Mifepristone and misoprostol regimen
Home use of mifepristone
A South African trial randomized people seeking abortion at up to 9 weeks gestation to a standard medical abortion service delivery model where: 1) mifepristone was ingested in the health center (n=350) or, 2) a telemedicine model where mifepristone was taken at home (n=372) (Endler et al., 2022). The trail found no difference in rates of abortion success, adherence to medication regimen, safety, or satisfaction between groups (Endler et al., 2022). Two prospective, non-randomized multicenter cohort studies conducted in the United States, which together included 701 women, showed that between a third and a half of women offered home or facility use of mifepristone chose home use (Chong et al., 2015; Swica et al., 2012). Women who used mifepristone at home were highly satisfied and had similar success rates and need for telephone or emergency room support as women who took mifepristone in the clinic. In similar studies conducted in Azerbaijan (Louie et al., 2014), Nepal (Conkling et al., 2015) and Kazakhstan (Platais et al., 2016), 74%, 72% and 64% of women, respectively, chose home use. The most commonly cited reasons for the choice to take mifepristone at home were flexibility, ability to schedule abortion around duties, partner’s presence and a more private experience. Abortion success rates were the same in the home use and clinic use groups. A population based cohort study conducted in Canada compared medical abortion safety outcomes before (n=7,269 medical abortions) and after (n=26,434 medical abortions) mifepristone became available for home use in that country, finding no difference in abortion safety outcomes (Schummers et al., 2022).
Home use of misoprostol up to 70 days
Two systematic reviews have confirmed the safety and effectiveness of misoprostol taken at home as part of a mifepristone-misoprostol regimen up to nine (Gambir et al., 2020) and 10 weeks gestation (Schmidt-Hansen et al., 2020). In Gambir et al. (2020), an examination of 19 prospective studies-three randomized controlled trials and 16 nonrandomized comparative trials including 11,576 people up to 63 days gestation-found that complete abortion rates and adverse event rates were the same for home- and facility-based misoprostol use . Women found home use as acceptable as clinic use. Schmidt-Hansen et al. (2020) compared the safety and effectiveness of home-based misoprostol for abortions up to 9 weeks gestation to those beyond 9 weeks, reported in 6 prospective and retrospective cohort studies including 3,381 people. The review found no difference in complete abortion rates or adverse events, confirming the safety and efficacy of home use of misoprostol up to 10 weeks
A systematic review of nine prospective comparative cohort studies including 4,522 women up to 56 days gestation showed that complete abortion rates and adverse event rates were the same for home- and facility-based misoprostol use (Ngo, Park, Shakur, & Free, 2011) as part of a mifepristone-misoprostol regimen. Women found home use as acceptable as clinic use. A non-randomized comparative trial including 731 rural and urban Indian women up to 63 days gestation found no difference in abortion success or adverse events between home and facility administration of misoprostol (Iyengar et al., 2016). Large observational studies up to 59 days (Fjerstad et al., 2009) and 63 days (Gatter, Cleland, & Nucatola, 2015; Goldstone, Walker, & Hawtin, 2017; Lokeland, Iversen, Engeland, Okland, & Bjorge, 2014; Louie et al., 2014; Raghavan et al., 2013) also confirmed the safety and effectiveness of home use of misoprostol at these gestational ages.
Two large prospective cohort studies from the United Kingdom reported on the safety and effectiveness of telemedicine for the provision of medical abortion during the COVID-19 pandemic (Aiken, Lohr, Lord, Ghosh, & Starling, 2021; Reynolds-Wright, Johnstone, McCabe, Evans, & Cameron, 2021). In these studies, 52,142 women (Aiken et al., 2021) and 642 women (Reynolds-Wright et al., 2021), respectively, used misoprostol at home up to 70 days gestation; complete abortion rates for both studies were greater than 98%, and serious complication rates were less than 1%. The Royal College of Obstetricians and Gynaecologists (RCOG, 2019), the American College of Obstetricians and Gynecologists (ACOG, 2014) and the National Abortion Federation (NAF, 2017) recommend offering home use of misoprostol up to 70 days gestation.
Since these reviews, a number of prospective and retrospective cohort studies have reported on the safety and effectiveness of telemedicine for the provision of medical abortion. In the largest prospective study, from the United Kingdom, 52,142 women who used misoprostol at home for abortions up to 70 days gestation, and reported a complete abortion rate greater than 98% and serious complication rate of less than 1% (Aiken et al., 2021). Several smaller prospective and retrospective cohort studies evaluating the safety and effectiveness of telemedicine abortion provision with home use of misoprostol have similar findings (Chong et al., 2021; Pena et al., 2022; Reynolds-Wright et al., 2021; Upadhyay, Koenig, & Meckstroth, 2021; Upadhyay et al., 2022). The Royal College of Obstetricians and Gynaecologists (RCOG, 2019) and the American College of Obstetricians and Gynecologists (ACOG, 2020) recommend offering home use of misoprostol up to 70 days gestation.
Home use of misoprostol from 10-13 weeks
The upper gestational limit where misoprostol may be safely used at home has not been well-established. A non-inferiority trial compared the effectiveness of a medical abortion regimen of 200mg mifepristone followed by a single dose of 800mcg buccal misoprostol taken at home 24-48 hours later among women with pregnancies of 64-70 days to those with pregnancies of 71-77 days (Dzuba et al., 2020). Investigators found a success rate of 92% in the earlier gestational age group compared to 87% in the later group, and significantly more ongoing pregnancies in the later group (9% compared to 4%), suggesting that additional doses of misoprostol are needed at gestations of more than 70 days. A subsequent retrospective cohort study compared success rates when two doses of misoprostol 800mcg were taken at home, four hours apart, for pregnancies between 64-70 days and 71-77 days (Dzuba et al., 2020a). Although a high loss to follow up (25%) limits conclusions that can be drawn, investigators found abortion success rates of greater than 99% and 98%, respectively. One small retrospective cohort study compared safety and effectiveness of home use of misoprostol for medical abortion at gestational age 57-63 days to home use from 64-76 days, where study participants self-administered a single dose of misoprostol 800mcg vaginally, followed by up to four additional doses of 400mcg if bleeding did not occur (Larsson, & Ronnberg, 2019). Success rates were 96% and 94%, with no difference in incomplete abortion, excessive bleeding, or surgical intervention. An additional retrospective cohort study where women self-administered two doses of misoprostol 800mcg at home for medical abortions up to 77 days found a similar success rate (96%) (Kerestes et al., 2021). A prospective cohort study from Scotland that reported on the safety and efficacy of telemedicine for mifepristone and misoprostol medical abortion during the COVID-19 pandemic included people with gestations up to 12 weeks (Reynolds-Wright et al., 2021). Of the 663 women included in the study, only 21 (3%) had gestations between 10 and 12 weeks. Almost all women (98%) had a successful abortion; there were nine abortion failures (1.4%), only one of which occurred after 10 weeks. There are no comparative data regarding home use of misoprostol as part of a combined regimen after 11 weeks gestation. Despite this, the World Health Organization (WHO) recommends that when pregnant people can self-manage the three component parts of the medical abortion process-self-assessment for eligibility, self-administration of abortion medicines and management of the abortion process, and self-assessment of the success of the abortion-up to 12 weeks gestation, when they have access to a source of accurate information and to a health-care provider, if needed. (WHO, 2022).
Misoprostol-only regimen
Although no studies have directly compared safety and effectiveness of home use of misoprostol in a misoprostol-only regimen to health facility use, a number of studies provide evidence to support the safety and effectiveness of misoprostol taken at home for medical abortion. Several randomized studies with misoprostol-only arms have allowed women to self-administer the medication at home up to nine weeks gestation without an effect on safety or medical abortion success (Blum et al., 2012; Ngoc et al., 2011; Sheldon et al., 2019) and several prospective cohort studies of misoprostol-only medical abortion up to 9 (Carbonell, Valera, Velazco, Fernandez, & Sanchez, 1997; Velazco et al., 2000), or between 9-12 gestational weeks (Carbonell et al., 2001) have allowed participants to self-administer misoprostol at home without an effect on safety or medical abortion success. Studies examining strategies to support safe and effective abortion outside the clinical setting, such as those exploring abortion accompaniment or community-based distribution of misoprostol for medical abortion self-management, have reported abortion success rates for misoprostol-only abortion that exceed those for facility based care (Moseson et al., 2020b). In the SAFE study, which documents effectiveness of abortion self-management with accompaniment support, 99% of the misoprostol-only users reported a successful abortion without surgical intervention (Moseson et al., 2022). Two studies have documented the safety and effectiveness of misoprostol-only, self-managed abortion accessed through community-based distribution up to either 9 or 10 weeks gestation; abortion success rates were 94-96% with no serious adverse events recorded (Foster, Arnott, & Hobstetter, 2017; Foster et al., 2022). One prospective cohort study conducted in Nigeria assessed success rates in pregnant individuals who purchased misoprostol from drug sellers to self-manage their medical abortion (Stillman et al., 2020). Despite receiving inadequate information about the drugs, what to expect, or where and when to seek additional care, 94% of the sample reported a complete abortion without surgical intervention. Of the sample, one participant required a blood transfusion.
References
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