Camille Lenoir1, Sabrina Boumaïza1, Kuntheavy R Ing Lorenzini1, Michel Boulvain2, Jules A Desmeules1, Victoria Rollason3. 1. Division of Clinical Pharmacology & Toxicology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals & University of Geneva, Geneva, Switzerland. 2. Department of Obstetrics & Gynaecology, Geneva University Hospitals, Geneva, Switzerland. 3. Division of Clinical Pharmacology & Toxicology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals & University of Geneva, Geneva, Switzerland. Electronic address: Victoria.Rollason@hcuge.ch.
Abstract
OBJECTIVE: We aimed to characterize drug exposures during pregnancy where the outcome was known that had benefited from counselling through our Teratology Information Service (TIS) between 1994-2016. STUDY DESIGN: This observational study analysed data collected through the drug exposures during pregnancy counselling. Data was analysed descriptively. RESULTS: Data from a total of 1'374 pregnant women were collected. Mean age was of 32 years. These women were exposed to more than ten drugs in 1.4 % (N = 19) of cases, with a mean drug intake of two. Analysis of the drugs altogether (N = 3'129) showed that FDA Pregnancy Category C drugs represented 42.9 % (N = 1'342) of drugs and ATC code N (nervous system) represented 36.4 % (N = 1'138). The onset of drug exposure was during the first trimester of pregnancy in 95.1 % (N = 2'982) of patients. Regarding outcomes, the rate of induced abortion was 10.8 % (N = 151), of pregnancy complications was 11.2 % (N = 157) and of malformations was 4.5 % (N = 49). CONCLUSION: Pregnant women counselled by our TIS take a mean of two drugs, ranging from one to 17. Drugs are from FDA Pregnancy Category C and ATC N drugs in most cases, 42.9 % and 36.4 % respectively. The rate of malformation of our cohort was of 4.5 %, close to the estimated spontaneous rate of malformation. This data gives a reassuring aspect of drug exposure in pregnancy but takes into account the outcome at birth only.
OBJECTIVE: We aimed to characterize drug exposures during pregnancy where the outcome was known that had benefited from counselling through our Teratology Information Service (TIS) between 1994-2016. STUDY DESIGN: This observational study analysed data collected through the drug exposures during pregnancy counselling. Data was analysed descriptively. RESULTS: Data from a total of 1'374 pregnant women were collected. Mean age was of 32 years. These women were exposed to more than ten drugs in 1.4 % (N = 19) of cases, with a mean drug intake of two. Analysis of the drugs altogether (N = 3'129) showed that FDA Pregnancy Category C drugs represented 42.9 % (N = 1'342) of drugs and ATC code N (nervous system) represented 36.4 % (N = 1'138). The onset of drug exposure was during the first trimester of pregnancy in 95.1 % (N = 2'982) of patients. Regarding outcomes, the rate of induced abortion was 10.8 % (N = 151), of pregnancy complications was 11.2 % (N = 157) and of malformations was 4.5 % (N = 49). CONCLUSION: Pregnant women counselled by our TIS take a mean of two drugs, ranging from one to 17. Drugs are from FDA Pregnancy Category C and ATC N drugs in most cases, 42.9 % and 36.4 % respectively. The rate of malformation of our cohort was of 4.5 %, close to the estimated spontaneous rate of malformation. This data gives a reassuring aspect of drug exposure in pregnancy but takes into account the outcome at birth only.