termination. There is now a vast world literature with more than 60,000 patients treated in France. Repetition of large Phase 3 trials in the United States (to demonstrate efficacy and document side effects) does not appear necessary.
Recommendation No. 8. The committee recommends expeditious submission to the U.S. Food and Drug Administration of all existing clinical trial data on mifepristone and prostaglandin for early pregnancy termination to determine whether these data meet current U.S. regulatory requirements.
Recommendation No. 9. The committee recommends that in considering the use of mifepristone and prostaglandin for early pregnancy termination in women who smoke more than 10 cigarettes per day or are over 35 (two groups of women who were excluded from European studies), the documented risks must be compared with the risks of continuing pregnancy or of surgical termination of pregnancy. Furthermore, such assessment should attempt to distinguish between the risks attributable to mifepristone and those attributable to prostaglandin.
At this point, the major research need in using antiprogestin for pregnancy termination is not in efficacy, but rather in health services research. The medical regimens appear to be safe and efficacious, as demonstrated by experience in France, Great Britain, and Sweden. However, the United States has a very different health care system in which access to reproductive health care is a major problem. Research can help clarify how to increase access to a medical program for terminating pregnancy, as well as provide benefit-cost analyses comparing the medical procedure to surgical termination of pregnancy. Another area of research includes the number of visits required to oversee this regimen safely. In France, pregnancies are terminated only in legally authorized centers and under a Roussel-Uclaf protocol requiring that medical termination occur before 49 days of amenorrhea. The protocol is administered during four required visits to the center. An initial visit documents pregnancy and educates the patient about the procedure; at a second visit, 600 mg of mifepristone is given. Thirty-six to forty-eight hours later, the woman returns to the clinic, and prostaglandin is administered either vaginally or orally. Patients are monitored as inpatients for at least four hours on the day of prostaglandin administration. They return for a fourth, follow-up visit 8 to 12 days