The prevention of prenatal alcohol use: a critical analysis of intervention studies.

Alcohol is a major cause of birth defects and mental retardation in the U.S. The yearly cost to care for those affected has been estimated to be over $300 million. Prenatal education and counseling have been advocated as techniques to reduce alcohol use in pregnancy. The purpose of this study was to critically review investigations that used these methods in order to determine their effectiveness. Reports of relevant studies were found by searching Medline, the ETOH database and bibliographies of primary sources. Only five studies were identified that met predetermined selection criteria. As judged by usual methodologic standards for intervention programs, only one was of acceptable quality. None employed a randomized design, and only two compared the treatment group to a control group. Both these studies found no difference in alcohol use between control and intervention groups. An ethical argument was used by several authors to justify performing inadequately controlled studies. Since no intervention has proven to be superior to the usual care delivered to pregnant women, this problem can be overcome through the use of controls who receive this level of care. Despite the public health importance of prenatal alcohol use, interventions to alter this behavior have not been rigorously evaluated, and the benefits of any specific approach are unclear. Randomized trials are ethically justified and guidelines for undertaking such studies are proposed.