Clinical Updates in Reproductive Health

Home use of medications up to 11 weeks gestation

Last reviewed: February 7, 2021

Recommendation:

  • Women may take mifepristone in a facility or at home.
  • Home use of misoprostol following mifepristone or in a misoprostol-only regimen may be offered up to 11 weeks gestation.
  • After 11 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

Traditionally, providers have given mifepristone to women in a facility to start the abortion process. Then 1-2 days later, women may take misoprostol in a health facility, their own home or another safe location. Because of women’s individual preferences for privacy, support and timing, they should have options about the location of mifepristone and misoprostol use.

Home use of mifepristone

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, Karki, Tuladhar, Bracken, & Winikoff, 2015) and Kazakhstan (Platais, Tsereteli, Grebennikova, Lotarevich, & Winikoff, 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. When a woman chooses home use of mifepristone, she should take it within one week of the clinic visit at which she received the prescription or medication, provided her pregnancy does not exceed 11 weeks at that time.

Home use of misoprostol up to 70 days

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.

A prospective cohort study of 729 women in the United States comparing a single dose of buccal misoprostol 800mcg at home from 57-63 days and from 64-70 days as part of a mifepristone-misoprostol regimen showed no difference between the groups in success rates, ongoing pregnancy or adverse events (Winikoff et al., 2012). A prospective cohort trial conducted in India, Georgia, Tunisia and Ukraine compared outcomes of 703 women who received mifepristone followed by 400mcg of sublingual misoprostol in the home for pregnancies of 57-63 days or 64-70 days gestation (Bracken et al., 2014). Success rates and ongoing pregnancy rates did not differ between groups, although women in the later gestational age group were more likely to receive an additional dose of misoprostol or require intervention for bleeding. Additional smaller studies have shown similar results (Boersma, Meyboom-de Jong, & Kleiverda, 2011; Platais et al., 2016; Tan et al., 2018). Two systematic reviews have confirmed the safety and effectiveness of home use of misoprostol up to nine weeks (Gambir, Kim, Necastro, Ganatra, & Ngo, 2020) and 10 weeks gestation (Schmidt-Hansen et al, 2020). 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.

The Royal College of Obstetricians and Gynaecologists (RCOG, 2015) recommends home use of misoprostol up to 63 days gestation. The World Health Organization (WHO) suggests that when women have access to a source of accurate information and to a health care provider, they can self-manage the abortion process up to 12 weeks gestation.  The WHO also calls for rigorous research to establish the safety, efficacy and acceptability of medical abortion in the outpatient setting for pregnancy from 9-12 weeks gestation (WHO, 2015; WHO, 2018).  

Home use of misoprostol from 10-13 weeks

While the safety and effectiveness of home use of misoprostol as part of a mifepristone and misoprostol combined regimen is well established up to 70 days gestation, 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 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 with 4% in the earlier group; pain, bleeding and acceptability between the groups were similar. Investigators were unable to conclude that the medical abortion regimen tested was noninferior across the two gestational age ranges, suggesting that additional doses of misoprostol are needed at gestations of more than 70 days. 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 women 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. 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 (Larsson, & Ronnberg, 2019). Women received mifepristone in the health center and self-administered a single dose of misoprostol 800mcg vaginally at home 36-48 hours later, followed by up to four additional doses of 400mcg if bleeding did not occur. Success rates were 96% and 94% in the earlier and later gestational groups, although more women in the later group had an ongoing pregnancy (one versus four). There was no difference in incomplete abortion, excessive bleeding, surgical intervention or unscheduled return visits between groups. There are no comparative data regarding home use of misoprostol as part of a combined regimen after 11 weeks gestation. The World Health Organization (WHO) suggests that when women have access to a source of accurate information and to a health-care provider, they can self-manage the abortion process up to 12 weeks gestation, despite this lack of evidence. WHO calls for rigorous research to establish the safety, efficacy and acceptability of medical abortion in the outpatient setting for pregnancy from 9-12 weeks gestation (WHO, 2015; WHO, 2018).

Misoprostol-only regimen

No studies have directly compared safety and effectiveness of home use of misoprostol in a misoprostol-only regimen to health facility use. However, several 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). Additionally, three small prospective cohort studies of misoprostol-only abortion conducted in Cuba allowed home use of medication up to 9 (Carbonell, Valera, Velazco, Fernandez, & Sanchez, 1997; Velazco et al., 2000), or between 9-12 gestational weeks (Carbonell et al., 2001) without an effect on safety or success. Two studies that enrolled only adolescents (Carbonell et al., 2001; Velazco et al., 2000) found higher rates of nausea and vomiting than observed in studies with adult women.

References

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American College of Obstetricians and Gynecologists. (2014). Practice bulletin No. 143: Medical management of first-trimester abortion. Obstetrics & Gynecology, 123(3), 676-692.

Blum, J., Raghavan, S., Dabash, R., Ngoc, N. T. N., Chelli, H., Hajri, S., … Winikoff, B. (2012). Comparison of misoprostol-only and combined mifepristone-misoprostol regimens for home-based early medical abortion in Tunisia and Vietnam. International Journal of Gynecology & Obstetrics, 118, 166-171.

Boersma, A. A., Meyboom-de Jong, B., & Kleiverda, G. (2011). Mifepristone followed by home administration of buccal misoprostol for medical abortion up to 70 days of amenorrhoea in a general practice in Curacao. The European Journal of Contraception and Reproductive Health Care, 16(2), 61-66.

Bracken, H., Dabash, R., Tsertsvadze, G., Posohova, S., Shah, M., Hajri, S., … Winikoff, B. (2014). A two-pill sublingual misoprostol outpatient regimen following mifepristone for medical abortion through 70 days’ LMP: A prospective comparative open-label trial. Contraception, 89(3), 181-186.

Carbonell, J. L. L., Velazco, A., Varela, L., Tanda, R., Sanchez, C., Barambio, S., … Mari, J. (2001). Misoprostol for abortion at 9-12 weeks’ gestation in adolescents. The European Journal of Contraception and Reproductive Health Care, 6, 39-45.

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Chong, E., Frye, L. J., Castle, J., Dean, G., Kuehl, L., & Winikoff, B. (2015). A prospective, non-randomized study of home use of mifepristone for medical abortion in the US. Contraception, 92(3), 215-9.

Conkling, K., Karki, C., Tuladhar, H., Bracken, H., & Winikoff, B. (2015). A prospective open-label study of home use of mifepristone for medical abortion in Nepal. International Journal of Gynecology & Obstetrics, 128(3), 220-223.

Dzuba, I.G., Chong, E., Hannum, C., Lichtenberg, S., Hernandez, E.M.L., Ngoc, N. … & Winikoff, B. (2020). A non-inferiority study of outpatient mifepristone-misoprostol medical abortion at 64-70 days and 71-77 days of gestation.  Contraception, 101, 302-308.

Fjerstad, M., Sivin, I., Lichtenberg, S. Trussell, J., Cleland, K., & Cullins, V. (2009). Effectiveness of medical abortion with mifepristone and buccal misoprostol through 59 gestational days. Contraception, 80(3), 282-286.

Gambir, K., Kim, C., Necastro, K.A., Gantatra, B., & Ngo, T.D. (2020). Self-administered versus provider-administered medical abortion. Cochrane Database of Systematic Reviews., Issue 3. Art No: CD013181.

Gatter, M., Cleland, K., & Nucatola, D. L. (2015). Efficacy and safety of medical abortion using mifepristone and buccal misoprostol through 63 days. Contraception, 91(4), 269-73.

Goldstone, P., Walker, C., & Hawtin, K. (2017). Efficacy and safety of mifepristone-buccal misoprostol for early medical abortion in an Australian setting. Australian and New Zealand Journal of Obstetrics and Gynaecology, 57, 366-371.

Iyengar, K., Klingberg-Allvin, M., Iyengar, S. D., Paul, M., Essen, B., & Gemzell-Danielsson, K. (2016). Home use of misoprostol for early medical abortion in a low resource setting: A secondary analysis of a randomized controlled trial. Acta Obstetricia et Gynecologica Scandinavica, 95(2), 173-181.

Larsson, A., & Ronnberg, A. M. (2019). Expanding a woman’s options to include home use of misoprostol for medical abortion up until 76 days: An observational study of efficacy and safety. Acta Obstetricia et Gynecologica Scandinavica, 98(6), 747-752.

Lokeland, M., Iversen, O.E., Engeland, A., Okland, I., & Bjorge, L. (2014). Medical abortion with mifepristone and home administration of misoprostol up to 63 days gestation. Acta Obstetricia et Gynecologica Scandanavica, 93(7), 647-653.

Louie, K.S., Tsereteli, T., Chong, E., Aliyeva, F., Rzayeva, G., & Winikoff, B. (2014). Acceptability and feasibility of mifepristone medical abortion in the early first trimester in Azerbaijan. The European Journal of Contraception and Reproductive Health Care, 19(6), 457-464.

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Ngo, T. D., Park, M. H., Shakur, H., & Free, C. (2011). Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: A systematic review. Bulletin of the World Health Organization, 89(5), 360-370.

Ngoc, N. T., Blum, J., Raghavan, S., Nga, N. T., Dabash, R., Diop, A., & Winikoff, B. (2011). Comparing two early medical abortion regimens: Mifepristone+misoprostol vs. misoprostol alone. Contraception, 83, 410-417.

Platais, I., Tsereteli, T., Grebennikova, G., Lotarevich, T., & Winikoff, B. (2016). Prospective study of home use of mifepristone and misoprostol for medical abortion up to 10 weeks of pregnancy in Kazakhstan. International Journal of Gynecology & Obstetrics, 134(3), 268-271.

Raghavan, S., Tsereteli, T., Kamilov, A., Kurbanbekova, D., Yusupov, D., Kasimova, F., … Winikoff, B. (2013). Acceptability and feasibility of the use of 400mcg of sublingual misoprostol after mifepristone for medical abortion up to 63 days since the last menstrual period: Evidence from Uzbekistan. The European Journal of Contraception and Reproductive Health Care, 18(2), 104-111.

Reynolds-Wright, J.J., Johnstone, A., McCabe, K., Evans, E., & Cameron, S. (2021). Telemedicine medical abortion at home under 12 weeks; gestation:  A prospective observational cohort study during the COVID-19 pandemic. BMJ Sexual & Reproductive Health, Published online first 4 February 2021. Doi: 10.1136/bmjsrh-2020-200976.

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Swica, Y., Chong, E., Middleton, T., Prine, L., Gold, M., Schreiber, C. A., & Winikoff, B. (2012). Acceptability of home use of mifepristone for medical abortion. Contraception, 88(1), 122-127.

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