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

OBJECTIVE

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).

DESIGN

An uncontrolled observational study.

SETTING

A public family planning center in Paris.

PATIENTS: Three hundred sixty-nine (369) pregnant women with up to 7 weeks amenorrhea undergoing legal abortion.

INTERVENTIONS: Six hundred milligrams (600 mg) of oral mifepristone followed 48 hours later by an IM injection of 250 micrograms of sulprostone.

MAIN OUTCOME MEASURES: 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.

RESULTS

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%].

CONCLUSION

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.