TRANSDERMAL NICOTINE REPLACEMENT IN PREGNANCY - MATERNAL PHARMACOKINETICS AND FETAL EFFECTS

OBJECTIVE: Our purpose was to measure any short-term effects that the transdermal nicotine replacement system may have in pregnancy and to v erify salivary nicotine and cotinine levels during patch placement. ST UDY DESIGN: After customary smoking cessation efforts had failed, six prenatal patients between 28 and 37 weeks' gestation who smoked betwee n one and two packs per day were enrolled in this prospective study. T he patients were admitted to the General Clinical Research Center for a period of 21 hours. During hospitalization we performed maternal and fetal assessments including vital signs, biophysical profile and elec tronic fetal monitoring, amniotic fluid index, and umbilical artery Do ppler examinations. Salivary samples far cotinine and nicotine levels were collected at standard intervals. RESULTS: There were no measurabl e differences in fetal or maternal well-being. During patch use saliva ry nicotine levels increased as expected, to a mean value of 19.0 +/- 13.5 mu g/L al 480 minutes. Salivary cotinine concentrations remained low (approximately 50 mu g/L) and Varied little during the 480-minute period that the patch was worn. Overall, patients were satisfied with the transdermal patches. CONCLUSION: There were no adverse maternal or fetal effects from the transdermal nicotine replacement system over t he 6-hour period. Salivary nicotine concentrations were consistent wit h those seen in nonpregnant adults. Surprisingly, salivary cotinine co ncentrations were much lower than those seen in smoking nonpregnant ad ults.