Medical termination of early pregnancy with mifepristone (RU 486) followed by a prostaglandin analogue: Study in 16, 369 women

We report the results of a large‐scale trial with mifepristonc (RU 486) followed by the administration of a prostaglandin (PG) analogue for the medical termination of early pregnancy. Altogether, 16,173 patients from 300 centers were evaluated. 48 women (0.3%) were lost to follow‐up prior to, and 416 (2.6%) after the PG administration, and therefore the efficacy was evaluated in 15,709 women. Overall. the success rate was 95.3%. with no statistical difference regarding the nature and dose of PG used. The median duration of bleeding was 8 days, being 12 days or less in 89.7% of the women. Bleeding was significant cnough to necessitate a vacuum aspiration or a dilatation and curettage in 0.8% of the cases. A blood transfusion was necessary in 0.1% of the women (11 patients). Serious cardio‐vascular side‐effects were reported in 4 cases after the PG (sulpro/tonc) injection: they consisted of one acute myocardial infarction attributed to a coronary spasm. and in marked hypotension in the other 3 woman. All patients recovered uneventfully. In conclusion, RU 486 followed by a PG analogue provides an efficient and safe medical alternative to surgery for early pregnancy termination, provided that the recommended protocol is adequately followed and the contraindications to prostaglandins are respected.