ABSTRACT. Context. The association between prenatal cocaine exposure and congenital anomalies is not definitive.Objective. To determine whether prenatal cocaine exposure results in an increased number or identifiable pattern of abnormalities.Design. A prospective, longitudinal cohort enrolled between 1991 and 1993.Setting. Rural public health population delivering at a regional tertiary medical center.Patients. Two hundred seventy-two offspring of 154 prenatally identified crack/cocaine users and 154 nonusing controls were matched on race, parity, location of prenatal care (that related to level of pregnancy risk), and socioeconomic status. Drug use was determined through repeated in-depth histories and urine screens. Infants not examined within 7 days of birth were excluded.Outcome Measures. Assessments were made by experienced examiners masked to maternal drug history. Included were 16 anthropometric measurements and a checklist of 180 physical features defined and agreed upon in advance.Results. There were no differences on major risk variables between the included and excluded infants. There were significantly more premature infants in the cocaineexposed group. Cocaine-exposed infants were significantly smaller in birth weight, length, and head circumference but did not differ on remaining anthropometric measurements. There was no difference in type or number of abnormalities identified between the exposed and nonexposed groups. There was no relationship between amount or timing of exposure and any of the outcomes.Conclusions. This prospective, large-scale, blinded, systematic evaluation for congenital anomalies in prenatally cocaine-exposed children did not identify an increased number or consistent pattern of abnormalities. A search for congenital malformations related to prenatal cocaine exposure has been underway since physicians became aware of the epidemic of prenatal use in the mid-1980s. Concern has been aroused because of a variety of case reports, small patient series, and retrospective studies reporting abnormalities of the skull, heart, skeleton, gastrointestinal tract, and genitourinary tract in infants born to women who used cocaine during pregnancy. [1][2][3][4][5][6][7][8][9][10][11][12][13] Over the years, the results of prospective studies have yielded somewhat conflicting outcomes. 14 -28 Methodologic concerns in many of these studies have precluded widespread acceptance of their findings, either positive or negative, leaving unanswered the question regarding the association between prenatal cocaine exposure and congenital anomalies.The most commonly identified mechanism of the effects of prenatal exposure involves the vasoconstrictive properties of cocaine. The proper growth and development of the fetus depend on a wellfunctioning vascular system. Vasoconstriction resulting in disruption of blood flow to the fetus could result in the development of structural abnormalities throughout gestation. 29,30 The purpose of this study was to determine whether prenatal cocaine exposure was associat...