Early medical abortion using low-dose mifepristone followed by buccal misoprostol: a large Australian observational study

Objective: To describe the use of mifepristone in combination with buccal misoprostol in women undergoing an early medical abortion (EMA) in Australia. Design, setting and participants: Retrospective, observational study of 13 345 EMAs (gestational age <= 63 days) conducted at 15 Marie Stopes International Australia clinics between 1 September 2009 and 31 August 2011. Intervention: Oral mifepristone 200 mg, administered at the clinic, followed 24-48 hours later by buccal misoprostol 800 mu g, self-administered at home. Main outcome measure: Failure rate (proportion of women with an incomplete abortion requiring surgical aspiration or a continuing pregnancy). Results: Pregnancy termination follow-up information was available for 83.4% (11 155/13 376) of EMAs. From the patient demographic database, the EMA failure rate was 3.5% (465/13 345). Of these, most (382; 2.9% of total) were incomplete abortions requiring surgical aspiration, and 83 (0.6% of total) were continuing pregnancies. Haemorrhage (16; 0.1%) and known or suspected infection (25; 0.2%) were infrequent. One woman, who did not seek follow-up despite signs of infection, died from sepsis (< 0.01%). In 6755 EMAs with clinic follow-up from April 2010 to August 2011, 6381 women participated in a survey. Most reported medium or heavy bleeding and moderate or severe pain/cramps; most also reported that bleeding, pain/cramps and their overall experience were as expected or better than expected. Conclusions: Mifepristone, with buccal misoprostol self-administered at home, for EMA up to 63 days of gestation had a low failure rate, was well accepted, and provided an effective treatment option with a favourable safety profile for women seeking an abortion in Australia.