Recommendation No. 9 addresses a group of potential patients excluded from previous trials. Recommendation No. 10 relates to the appropriate setting for use of the drug combination, reflecting the committee's concern that the imposed criteria of four medical visits, as set by protocols from the innovator-manufacturer, may not be necessary or acceptable to patients in the United States.
Currently, second-trimester pregnancy termination is available in the United States by dilation and evacuation (D&E), by intra-amniotic saline injection, by intra-amniotic prostaglandin F, or by prostaglandin E2 suppositories. A series of clinical studies has suggested that treatment with mifepristone before the administration of prostaglandin significantly decreases the level of prostaglandin needed to complete an abortion and shortens the time interval from administration to abortion. Overall, in clinical studies to date, the use of antiprogestins for this purpose during the second trimester has been well tolerated with minimal side effects.
Given the multiday admission required for a second-trimester prostaglandin abortion, as well as the high level of discomfort for the woman, the ability to shorten by one day the duration of hospitalization using antiprogestin would be significant.
Recommendation No. 11. With regard to second-trimester abortion, the committee recommends conducting clinical trials in the United States to compare the established surgical procedure of dilation and evacuation (D&E) both to antiprogestins in combination with prostaglandins and to prostaglandins used alone. Such trials should clarify the optimal dose of antiprogestin and prostaglandin for this use, and should assess relative pain, interval to fetal expulsion, blood loss, and frequency of infection, uterine perforation, and incomplete expulsion requiring surgical intervention.
The application of mifepristone for cervical ripening has been tested and shows promise. This property may help to manage clinical situations such as (1) preparation for second-trimester abortion, (2) preparation for labor induction at term, and (3) preparation of the cervix when labor must be induced because of intrauterine fetal demise. Because of the discomfort associated with either elective termination of second-trimester pregnancy or the termination of the genetically abnormal or