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A multi-centre, randomized trial was conducted to compare the efficacy and side-effects of two combination regimens of the antiprogestin RU 486 and the intramuscular PGE2 analogue sulprostone for termination of early pregnancy (amenorrhoea up to 49 days). Women in the 3-day group ( = 125) received 25 mg RU 486 twice daily for 3 days plus a single injection of 0.25 mg sulprostone in the morning of the third day of antiprogestin treatment. In the 4-day group (n = 126), RU 486 was given for 4 days and the sulprostone injection in the morning of the fourth day. Treatment outcome in the two groups was similar. Overall, 88.8% had a complete abortion, 6.8% an incomplete abortion and 2.4% were treatment failures; in the remaining 2% treatment outcome could not be determined. Only three of the six women with treatment failure still had detectable fetal heart activity when the pregnancy was terminated by vacuum aspiration two weeks after the start of treatment. Five of the 17 interventions for incomplete abortion were carried out as emergency procedures because of heavy bleeding; two of these five women were given a blood transfusion. The majority of the curettages (10/17) were performed in one centre. If the data from this centre and the women with undetermined treatment outcome were excluded, the rates for complete abortion, incomplete abortion and treatment failure in the remaining six centres were 93.6, 3.7 and 2.7%, respectively. Neither of the two treatment regimens caused any significant side-effects except for lower abdominal pain which was reported by 88.5% of the women following sulprostone injection and led to the use of narcotic analgesics in 7.6% of the subjects. Use of analgesia varied markedly between centres, however. Treatment was more likely to fail in subjects who were heavier and in those with a larger amniotic sac or higher levels of /3-HCG and progesterone prior to therapy. [ABSTRACT FROM PUBLISHER]