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Analysis of 369 abortions conducted by mifepristone (RU486) associated with sulprostone in a French family planning center

1994; Elsevier BV; Volume: 61; Issue: 4 Linguagem: Inglês

10.1016/s0015-0282(16)56637-0

1556-5653

Patrick Thonneau, Beatrice Fougeyrollas, Alfred Spira,

Maternal and fetal healthcare

To investigate the use of oral mifepristone (RU486; Roussel-Uclaf, Paris, France) associated with IM injection of sulprostone (Schering, Lys-Lez-Lannoy, France) for the induction of legal abortion (7 weeks of amenorrhea in France).An uncontrolled observational study.A public family planning center in Paris.Three hundred sixty-nine (369) pregnant women with up to 7 weeks amenorrhea undergoing legal abortion.Six hundred milligrams (600 mg) of oral mifepristone followed 48 hours later by an IM injection of 250 micrograms of sulprostone.Frequency of complete abortion and the need for subsequent surgical evacuation, hospitalization, and blood transfusion. Measurement of the beta-hCG concentration before and 14 days after the oral administration of mifepristone.There was complete abortion in 93.2% of the cases. Of the 25 failures, 8 were continued pregnancies, 6 terminated pregnancy but without expulsion of the conceptus, and 11 were placenta retentions. Eight women required short hospitalization, but none needed blood transfusion. Among the 25 failures, 23 had a beta-hCG concentration > 500 IU/mL [sensitivity 92%, specificity 83%].The sequential use of oral mifepristone and IM injection of sulprostone is effective in inducing abortion up to 7 weeks of amenorrhea. Nevertheless the risk of maternal morbidity associated with sulprostone and also the risk of fetal malformations in cases of continued pregnancy indicate that this method should only be used in specialist centers.The recent use of mifepristone (RU-486) and sulprostone for abortion in France was evaluated in this study. Previous studies had reported an abortion success rate of nearly 97%. In addition, factors which could result in failure were identified during this retrospective study. There were 369 women who underwent the RU-486 induced abortion between 1989 and 1991. All women were examined and cleared of any conflicting factors for the purposes of this study. Every patient was given a single 600 mg oral dose of RU-486 and then, 48-hours later, given an intramuscular injection of sulprostone (250 ml). Every patient was observed for 4 hours at the family planning center and seen 14 days after drug administration. Personal and historical data on each patient was collected from physician interviews and standard questionnaire. Statistical analysis was completed using the statistical analysis systems (SAS) software package for chi-square (X2), Student's t-test, Cochran-Mantel-Haenszel adjusted X2 tests, and logistical-regression analysis. Pregnancy was confirmed in all women before admission into this study by measurement of the serum beta-hCG concentration and/or uterine ultrasound (US) scan. There were 25 abortion failures recorded (6.8%, 95% confidence interval [CI], 4.2-9.4%). Of these, 23 (92%) occurred in women who had serum beta-hCG levels greater than 500 IU/mL 2 weeks after RU-486 administration (odds ratio [OR] 42.3; 95% CI, 9.7-185.6%). Of those women who did abort, 42% expelled the conceptus within 4 hours of sulprostone injection. Complete abortions were recorded in 93.2% of the women. There was no significant correlation between sociodemographic or gynecological variables and abortion failures.