A large study has found mifepristone-buccal misoprostol use for pregnancy termination up to 63 days gestation is an “effective and safe alternative” to surgical abortion
An observational cohort study has examined the use of the drug combination in more than 15,000 women who attended one of 16 Marie Stopes International clinics in Australia between March 2013 and September 2015, for an early medical abortion.
Early medical abortion (gestational age ≤ 63 days) involved administration of 200mg oral mifepristone (RU486) in-clinic followed 24-48 hours later by 800µg buccal misoprostol self-administered at home.
Decision-based counselling was also offered at the time of screening, and written informed consent was obtained by a doctor along with a discussion of the procedure and potential risks.
In the study led by Dr Philip Goldstone, Medical Director of Marie Stopes International in Australia, follow-up information was available for 87% (13,078) of women.
The medical method was found to be successful in 95.16% of women with follow-up (95% CI, 94.78-95.52%).
Success rates were highest in women with gestational age ≤35 days and decreased with increasing gestational age.
And method success was higher in younger women, with method success highest in women aged from 14 to 19 years, followed by those aged 20-24 years.
Overall, 674 serious adverse events were reported in the study, with most related to cases of method failure.
Incomplete abortion requiring surgical intervention was reported by 633 women (4.84%), while continuing viable pregnancy was reported by 99 (0.76%).
Infection (0.11%) and haemorrhage (0.13%) were rare.
There was one reported ectopic pregnancy resulting in salpingectomy, and one recorded death of a woman diagnosed with necrotising pneumonia.
This patient had a history of pulmonary embolism, and the relationship between her pregnancy termination and death was concluded to be “uncertain”.
Limitations of the study include lack of available data on efficacy and safety outcomes for women lost to follow-up, which the authors say may have introduced systematic bias into estimations of method success and complications.
However, “overall, oral mifepristone followed by buccal misoprostol was an effective and safe method of abortion up to 63 days gestation,” they conclude.
“Findings from this study provide further evidence of the efficacy and safety of mifepristone-buccal misoprostol for use up to 63 days gestation in an Australian setting.”
The results come on the back of Wednesday’s announcement that the Northern Territory Parliament has decriminalised abortion – and legalised access to RU486 – for women across the state.