title: Medical termination of early pregnancy with mifepristone (RU 486) followed by a prostaglandin analogue. Study in 16,369 women.
abstract: We report the results of a large-scale trial with mifepristone (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 enough 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 (sulprostone) injection: they consisted of one acute myocardial infarction attributed to a coronary spasm, and in marked hypotension in the other 3 women. 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.
authors.affiliation: Laboratoires Roussel, Paris, France.
authors.forename: A
authors.initials: A
authors.lastname: Ulmann
authors.forename: L
authors.initials: L
authors.lastname: Silvestre
authors.forename: L
authors.initials: L
authors.lastname: Chemama
authors.forename: Y
authors.initials: Y
authors.lastname: Rezvani
authors.forename: M
authors.initials: M
authors.lastname: Renault
authors.forename: C J
authors.initials: CJ
authors.lastname: Aguillaume
authors.forename: E E
authors.initials: EE
authors.lastname: Baulieu
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal; D000028:Abortion, Induced; D000328:Adult; D000527:Alprostadil / Q000031:analogs & derivatives; D015232:Dinoprostone / Q000031:analogs & derivatives; D004341:Drug Evaluation; D005260:Female; D005602:France; D006801:Humans; D015735:Mifepristone; D011247:Pregnancy; D011459:Prostaglandins E, Synthetic
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D011459:Prostaglandins E, Synthetic; D015735:Mifepristone; C021182:gemeprost; C016767:sulprostone; D000527:Alprostadil; D015232:Dinoprostone