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 µg, 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.