TABLE B5.1 Termination of Early Pregnancy by 600 mg Mifepristone and Vaginal Administration of 1.0 mg Gemeprost or 0.25 mg Sulprostone Intramuscularly

 

French Multicenter Study (<49 days)

U.K. Multicenter Study (<63 days)

 

Gemeprost (%)

Sulprostone (%)

Gemeprost (%)

Complete abortion

96.5

95.4

94.0

Incomplete abortion

2.3

2.8

5.0a

Ongoing pregnancy

0.4

0.6

 

Hemostatic surgical procedure

0.8

0.4

1.0

a In the United Kingdom study, separate figures for incomplete abortion and ongoing pregnancy are not given.

SOURCE: U.K. Multicentre Trial (1990); Ulmann et al. (1992).

Mifepristone in Combination with Prostaglandin

The outcome of treatment is quite different if mifepristone is combined with prostaglandin. In the first study with the combined therapy, 25 mg mifepristone was given twice daily for three to six days. On the last day, 0.25 mg sulprostone (Schering AG, Berlin, Germany) was injected intramuscularly (Bygdeman and Swahn, 1985). The overall frequency of complete abortion was 94 percent. Success rates between 95 and 100 percent were also reported in similar studies where mifepristone was combined with vaginal administration of 0.5 to 1.0 mg gemeprost May and Baker, Dagenham, U.K., 1990 (Cameron et al., 1986; Dubois et al., 1988).

Today mifepristone is available for routine clinical use in France, Great Britain, and Sweden. The dose schedule recommended by the pharmaceutical company (Roussel-Uclaf, Paris) is a single dose of 600 mg mifepristone followed 36 to 48 hours later by 1.0 mg gemeprost. Sulprostone, which was mainly used initially, is no longer available since the intramuscular preparation has been withdrawn from the market. In Sweden and Great Britain the procedure is used through the eighth week of pregnancy (63 days of amenorrhea), whereas in France the upper limit is 49 days of amenorrhea. The clinical outcome of the treatment has been evaluated in two large multicenter clinical studies from France and Great Britain (U.K. Multicentre Trial, 1990; Ulmann, 1992). Mifepristone followed by either vaginal gemeprost or intramuscular injection of sulprostone was shown to be highly effective in terminating early pregnancy. The frequency of complete abortion was around 95 percent, and complete failures in terms of continued pregnancy occurred in about 0.5 percent of the patients (Table B5.1). The clinical events are very similar to those of a spontaneous abortion, with



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