Efficacy and safety of mifepristone-buccal misoprostol for early medical abortion in an Australian clinical setting

Aust N Z J Obstet Gynaecol. 2017 Jun;57(3):366-371. doi: 10.1111/ajo.12608. Epub 2017 Mar 17.


Background: In 2014, a composite pack containing mifepristone-buccal misoprostol, indicated for use to 63 days gestation replaced the existing regimen for early medical abortion (EMA) in Australia.

Aims: To provide updated efficacy and safety information for the use of mifepristone-buccal misoprostol for EMA in Australia, and assess the effect of patient age and gestational age on efficacy.

Materials and methods: Observational cohort study of 15 008 women attending one of 16 Marie Stopes International clinics in Australia for an EMA (gestational age ≤ 63 days) between 1 March 2013 and 30 September 2015. Administration of 200 mg oral mifepristone in-clinic was followed 24-48 h later by 800 μg buccal misoprostol self-administered at home. Method success was defined as complete abortion not requiring surgical intervention.

Results: Follow-up information was available for 87.14% (13 078/15 008) of women. Likelihood of follow-up was significantly lower for women from rural or remote locations (adjusted odds ratio, 0.47; P < 0.001). Medical abortion was successful in 95.16% (12 445/13 078) of women with follow-up. Higher patient and gestational ages were associated (P < 0.001) with a slight increase in method failure. There were 674 serious adverse events (5.15%), mainly due to method failure. Infection (15; 0.11%) and haemorrhage (17; 0.13%) were rare. One death was recorded (<0.01%); however, an association between EMA and cause of death, necrotising pneumonia, was not established.

Conclusion: Mifepristone-buccal misoprostol is an effective and safe alternative to surgical termination of pregnancy up to 63 days gestation.

Keywords: abortion; early medical abortion; medical abortion; mifepristone-buccal misoprostol; termination of pregnancy.

Publication types

  • Multicenter Study

MeSH terms

  • Abortifacient Agents, Nonsteroidal* / adverse effects
  • Abortifacient Agents, Steroidal* / adverse effects
  • Abortion, Induced / methods*
  • Administration, Buccal
  • Administration, Oral
  • Adolescent
  • Adult
  • Australia
  • Female
  • Gestational Age
  • Humans
  • Maternal Age
  • Middle Aged
  • Mifepristone* / adverse effects
  • Misoprostol* / adverse effects
  • Pregnancy
  • Pregnancy Trimester, First
  • Prospective Studies
  • Young Adult


  • Abortifacient Agents, Nonsteroidal
  • Abortifacient Agents, Steroidal
  • Misoprostol
  • Mifepristone