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Analysis of the impact on newborns of prescriptions filled drugs use during pregnancy

Grant number: 15/05795-7
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): July 01, 2015
Effective date (End): June 30, 2016
Field of knowledge:Health Sciences - Medicine - Maternal and Child Health
Principal researcher:Carlos Alberto Lazarini
Grantee:Enrique Caetano Raimundo
Home Institution: Faculdade de Medicina de Marília (FAMEMA). Secretaria de Desenvolvimento Econômico (São Paulo - Estado). Marília , SP, Brazil

Abstract

Pregnancy is a time of anxiety and expectations for every woman and there is an exposure of two organisms to external and internal interference environment. Until the 1960s, it was believed that the placental barrier was impassable, until fetal malformations arising out of the use of Thalidomide to pregnant women, which affected thousands of children throughout the world, showed the opposite. In an attempt to standardize and guide the prescription of drugs, the Food and Drug Administration (FDA) introduced the risk categories of medications used by pregnant women, classifying them by a system of 5 letters with increasing risk: A, B, C, D and X. However, the lack of knowledge on the subject is still great. Clinical Research in this area are scarce since ethical and moral aspects limit the achievement of randomized clinical trials in pregnant women whose safety of medicines for the fetus is unknown. Observational studies are considered viable alternatives and important for research in the area because of the great number of drugs to which women are exposed throughout gestation. In a recent study of the research group in Pharmacoepidemiology of Marília School of Medicine, we assessed the use of medicines, prescribed and non-prescribed, in a random sample of 401 pregnant women in the city of Marília, in the year 2014. It was found that an average of 2.18 medications per pregnant woman, excluding vitamins and ferrous sulfate, of which 9.7% belonged to the category A of the FDA, 68% for B, 20.6% to C and 1.6% to D. Not found use of medicinal product of class X. Giving continuity to this research, the aim of this study is to assess if the medications used during pregnancy interfere in parameters of delivery (delivery type and gestational age) and newborns (Apgar, length, weight, head circumference). These data will be obtained from the medical records of 401 users of Basic Health Units and Family Health Units studied in previous work. The data will be entered in Excel 2000 spreadsheet for Windows. The statistical analyzes will be carried out with the software Statistical Package for Social Sciences (SPSS) version 17.0 for Windows. The inferential analyzes shall be carried out by means of Pearson's Chi-square Test and the extension of Fisher's Exact test, with a significance level (p < 0.005). Other tests, which the team collaborator from. Department of Mother-and-Child Health School of Public Health - FSP/USP represented in our study by Dr. Flávia Cristina Goulart deems necessary, may be made. Observing the precepts of ethics in research with human beings, the work will only be initiated after approval by the Research Ethics Committee of the Faculty of Medicine of Marilia and by the Municipal Council of Evaluation in Search of the Municipal Health Department of Marilia (COMAP).

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