after mifepristone administration (Bygdeman, Appendix B5). The apparent safety and efficacy of orally administered misoprostol (which does not require either parenteral administration or refrigeration) raise the possibility of fewer visits for this medical procedure (see also Grimes, Appendix B7). Advantages of this medical procedure are decreased cost (in Sweden, providers are reimbursed $600 for a surgical abortion and $300 for a medical abortion; Bygdeman, IOM workshop), as well as an increased sense of patient privacy and autonomy during the procedure. The safety of decreasing the number of patient visits to the physician must be evaluated.
In the United States, patient acceptability and access are major issues. Although the medical antiprogestin regimen (as distinct from surgical protocols) has found widespread patient acceptability in Europe (David, 1992; Winikoff et al., 1992), the committee suggests additional studies to determine appropriate protocols for this country, which may vary from those used elsewhere. Such research should help to define the optimal number of visits, appropriate doses and delivery route, and patient acceptability and access, including how best to ensure equal access for U.S. women of all economic and social classes.
Recommendation No. 10. With respect to using mifepristone for first-trimester termination of pregnancy, health services research should be conducted in the United States to determine which approaches (e.g., required number of visits, type of health care provider administering the drugs, site of service delivery) are most suitable from the standpoint of safety, efficacy, accessibility, and acceptability.
The committee does not recommend that consideration of a New Drug Application by the Food and Drug Administration for the use of mifepristone for pregnancy termination be delayed until the research outlined in Recommendations Nos. 9 and 10 has been completed. 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.
Although the specific mechanisms of human labor and delivery are not fully understood, several methods have been examined for inducing