The effects of RU-38486 on cervical ripening. Clinical studies

One hundred eighty pregnant patients, 17 to 39 years old (mean (+)/- SEM: 25.1 (+)/- 0.39), with an amenorrhea of 7 to 12 weeks (mean (+)/- SEM: 9.4 (+)/- 0.10), and requesting a therapeutic abortion, were selected according to general good health and gave their informed consent to the study. Mifepristone (RU-486; Roussel UCLAF, Paris, France) an antiprogestin steroid, was administered at random in doses of 0, 50, 100, 200, 400, or 600 mg. Clinical evaluations and measurements of cervical dilatation were done before the study and repeated at 24 hours after administration of Mifepristone and at 48 hours, at which time the aspiration was performed. Significant increases in cervical dilatation were observed at 48 hours with all doses of Mifepristone above 50 mg. The increases were significantly greater in patients with a gestational age greater than 10 weeks than in those less than 10 weeks' gestational age. Parity had no influence on cervical dilatation at 48 hours. Bleeding was observed significantly more often with 100 to 600 mg doses of Mifepristone than with 0 to 50 mg. No influence of gestational age or parity on bleeding could be detected. Abdominal cramps were reported more frequently with 200, 400, and 600 mg of Mifepristone at 48 hours and their occurrence appeared to parallel cervical dilatation.