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

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 mu g 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.