Registre i seguiment del desenllaç dels embarassos exposats a possibles teratògens

Abstract

ntroduction.- The data on the safety of drugs during pregnancy are few and difficult to interpret when you want to do a risk-benefit assessment. The need for experts to help interpret them led to the creation of information services on teratogen agents (TIS), and the need to generate information on the safety of drugs during pregnancy, at the grouping of cases and TIS’s collaboration. Since 1984 the Clinical Pharmacology Service (CPS) of the Vall d'Hebron University Hospital (VHUH) attend enquiries on therapy in pregnant women, in 2003 the Centre joined the network ENTIS (grouping of European TIS). Objective.- Describe the characteristics of enquiries requested about pregnant women who have taken (or have to take) medicines, or have been exposed to other potential teratogenic and describe the outcome of their pregnancies. Material and methods.- We performed an observational study of enquiries received from June 2010 to June 2014 to the CPS on VHUH about pregnancy. Have included inquiries from VHUH referring to patients and have been excluded the consultations from other sources, about general information, paternal treatment, pre-gestation or post-birth cases. It created a database and analyzed with statistical software IBM SPSS Statistics version 20. Results.- 264 requested enquiries were included. 93.6% the consulters were obstetricians, 95.4% were about the teratogenic risk assessment and the majority were made when the woman was in the first trimester (75% by week 16). It could track 234 pregnant women. Its median (IQR) age was 32 (28-36) years and the median (IQR) BMI of 23.4 (21.5-27.1) kg/m2. 34.6% had consumed some toxics (alcohol, tobacco, drugs) and 84.6% had clinical antecedents. The main purposes of the consultations about with follow-up pregnancies were medicines (> 90%). The therapeutic groups consulted were the N (38.5%), J (11.6%) and L (9.6%); the subgroups therapeutic were psicolèptics (10.8%), psiconalèptics (9.4%) and antiepileptics (8%), and the therapeutic drug, ibuprofen (3%), omeprazole (2%) and amitriptyline (1.8%). 24.4% of pregnancies were complicated. The women took other medicines what were not consulted mainly group B (21.5%), A (18.8%) and N (15.8%); subgroup of antianaemics (14.5%), antibiotics (11.6%) and analgesics (10.2%) and therapeutic drug such as paracetamol (8.9%), cyanocobalamin (7.3%) and iron (7.3%). In 68.7% of medicines consulted and 24.8% not consulted, there were doubts about its safety; in 20.9% and 73.9%, respectively, were compatible with pregnancy and 10.4% and 1.3%, respectively, were contraindicated (p <0.001). 26% of pregnancies ended in fetal loss, and 74% in live infants. Of the latter, 86% were born without anomalies and 6.2% with a major congenital malformation. The most common were the cardiovascular diseases (9 cases). In the babies were detected 26 other postnatal disorders. Significantly women with fetal loss had more medical history (92.8%) than women with newborns, with (64%) or without anomalies (84.3%); women with babies with abnormalities had more pregnancy complications (40%) than women without babies with abnormalities (31.4%) or fetal losses (7.2%). Women with babies with postnatal alterations said they consumed abuse drugs more (19.2%) than women with newborns without alterations (5.3%) and also suffer more pregnancy complications (53.8% and 28.9%, respectively). There were also differences in exposures to therapeutics drugs between these three groups and also depending to whether they had been consulted or not. Conclusions: This study has allowed us to make a first assessment of the possibility of monitoring of pregnancies that are the subject of consultation.

Date of Award	9 Sept 2016
Original language	Catalan
Awarding Institution	Vall d'Hebron University Hospital (HUVH)
Supervisor	M. Antonieta Agusti Escasany (Director) & Albert Jesús Figueras Suñé (Tutor)