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Title: Medical termination of early pregnancy with mifepristone (RU 486) followed by a prostaglandin analogue. Study in 16,369 women.
Author: Ulmann A, Silvestre L, Chemama L, Rezvani Y, Renault M, Aguillaume CJ, Baulieu EE.
Journal: Acta Obstet Gynecol Scand; 1992 May; 71(4):278-83. PubMed ID: 1322621.
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. Between May 1988 and September 1989, physicians administered 600 mg of RU-486 followed by either 1 mg gemeprost vaginal pessary or im injection of 0.125-1.0 mg sulprostone to 16,369 11-48 year old women attending 30 centers in France to evaluate this regimen's safety and efficacy and whether trained prescribers could adequately comply with recommended protocol. 13.6% patients whose gestational age was greater than the recommended 50 days, underwent RU-486 and prostaglandin (PG) analogue administration. 78% of 571 patients did not receive a PG analogue because they expelled the conceptus after RU-486 administration. The remaining 126 women did not receive RU-486 even though they had not expelled the conceptus. Clinicians administered to PG analogue to 88.4% of all women within the recommended 36-48 hours after RU-486 administration. The RU-486 and PG analogue regimen had a success rate of 95.3%. Women who received the PG analogue within the recommended time period had a higher success rate than those who received it either too early or too late (95.8% vs. 92.8% and 93.9%, respectively; p = .001). In those women who did not receive the PG analogue, RU-486's success rate was considerably lower (88.6%; p .001). The nature and does of the PG analogue greatly influenced expulsion within 4 hours after its administration (44.1% after 1 mg gemeprost vs. 57.3%, 55.8%, 73.5%, and 67.6% after 0.125, 0.25, 0.375, and 0.5 mg sulprostone respectively; p .001). The higher doses of sulprostone had a significant effect on duration of bleeding (e.g., 9.1 days for 0.5 mg vs. 7.1 days for 0.125 mg p .001). 89.7% of the women bled for no more than 12 days. The bleeding was so profuse in 0.8% of the cases that either vacuum aspiration or dilatation and curettage was needed. 11 women required 1-3 units of blood. 8.5% experienced at least 1 side effect, the most common being uterine cramps (1.6% of all cases). 4 women suffered from grave cardiovascular effects (myocardial infarction in 1 case, severe hypotension in 3 cases). As long as prescribers consider contraindications and follow the protocol, this regimen is a viable alternative to surgical abortion.

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