A randomized prospective study of misoprostol or mifepristone followed by misoprostol when needed for the treatment of women with early pregnancy failure.

Objective: To compare the effectiveness and safety of misoprostol and mifepristone, followed when needed by misoprostol, for the treatment of women with early pregnancy failure.

Design: Prospective randomized nonblinded controlled trial.

Setting: University-affiliated tertiary medical center.

Patient(s): One hundred fifteen consecutive women diagnosed as having a blighted ovum or missed abortion of <9 weeks of gestation enrolled.

Intervention(s): The patients received orally 600 mg mifepristone (group I) or orally 800 microg misoprostol (group II). Most patients in both groups subsequently received 48 hours later orally 800 microg misoprostol.

Main Outcome Measure(s): Failure was defined as surgical intervention due to retained gestational sac 48 hours after completion of the drug protocol, severe symptoms, or suspected retained products of conception after the menstrual period.

Result(s): The success rate was similar in groups I and II: 38 of 58 patients (65.5%) versus 42 of 57 patients (73.6%), respectively. No cases of severe infection or bleeding necessitating blood transfusion occurred.

Conclusion(s): Misoprostol is an effective and safe treatment for early pregnancy failure and could replace surgical curettage in over two-thirds of the patients. Mifepristone offers no advantage compared with misoprostol as initial treatment.