Evaluation of pregnancy outcomes of drug and radiation exposed pregnant women applied to Dokuz Eylul University Teratogen Information Service

ObjectiveThe aim of the study was to evaluate the pregnancy outcomes of the women who applied for teratogenity risk assessment related to exposed medication and radiation to Dokuz Eylul University (DEU) Teratogenity Information Service (TIS). Consistencies among FDA (Food and Drug Administration), TERIS (Teratogen Information System) and ADEC (Australian Drug Evaluation Committee's) pregnancy risk categories were compared by each other.MethodsThe pregnant women who exposed a medication and radiation between 01.01.2005 and 30.06.2007 were enrolled to this cross-sectional study. All of the detailed information about demographics of the pregnant women, exposed medication and radiation were recorded on a standardized form. Age, pregnancy number, presence of dead delivery, miscarriage, smoking habbit, occupation, education level of the woman and her husband were the independent variables; miscarriage, dead delivery or curettage were dependent variables. All of the data transferred into Statistical Package for the Social Sciences (SPSS) for Windows Release 11.0.1., were analyzed by Student?s t test, chi-square and logistic regression. The consistencies of drugs according to pregnancy risk categories were calculated by kappa consistency test.ResultsOf the 220 pregnants, 67.4 % of them were between 20 and 34 years old. Mean age was 29.1±5.5 (15?43 age) and mean pregnancy week was 8.2±4.4 (3?28 week). High risk teratogenic medication use according to FDA classification was 29.1 % (n=64). Most of the pregnancies (74.1 %, n=163) completed with delivery. Only 17.3 % (n=38) of the pregnancies completed with voluntary or medical curettage. The voluntary or medical curettage ratio were higher in pregnant with high risk medication use than that of low risk medication use according to FDA (OR:2.32, CI:1.13?4.77, p=0.032). Antiinfective and central nervous system medications were the most common exposed medications (24.6%, 24.1% respectively). Consistency of the pregnancy risk categories of the medications were 0.379, 0.454 and 0.221; between FDA and ADEC, TERIS and ADEC, TERIS and FDA, respectively.ConclusionIn our cross-sectional study, the higher teratogenic risk medication use according to the FDA risk categories caused the higher voluntary or medical curettage. Because of the low consistency of pregnancy risk categories, in the curettage decision, literature about the used medication must be taken into consideration.Key wordsTeratogenity, Teratogen Information Service (TIS), pregnancy, drug, radiation, FDA, TERIS, ADEC