[Evaluation of the teratogenic risks in gestations exposed to misoprostol].
OBJECTIVE
failed attempted abortions with the use of misoprostol (Cytotec(R)) without medical indication have been associated with the occurrence of congenital malformations. The objective of the present study was to identify, in newborns with malformations and in normal controls, the frequency of exposure to misoprostol and the spectrum of associated malformations.


METHODS
this was a case-control study involving a daily survey at four public maternities in Fortaleza (CE) for the identification of newborns with malformations and paired controls (1:1) during the period from July to November 2005. The sample comprised 252 parturients interviewed by a trained team by means of a structured questionnaire based on the Latin American Collaborative Study of Congenital Malformations (Estudo Colaborativo Latino-Americano de Malformações Congênitas, ECLAMC). The questionnaire was used to obtain sociodemographic data and a family history of malformations, as well as to identify diverse forms of exposure during pregnancy, including misoprostol. Bivariate analysis and the chi-square test were used to compare cases and controls regarding their characteristics and factors associated with malformation, and the Odds Ratio was calculated to determine the chance of the Case Group to present malformations as compared to the Control Group after exposure to misoprostol.


RESULTS
there were no significant differences between groups regarding most of the risk factors for malformations investigated. Attempted abortion was reported by 6.8% of the mothers, with a higher exposure to misoprostol during pregnancy resulting in a greater proportion of malformed newborns, Odds Ratio (OR)=3.65 (95%CI=0.74-17.91). The spectrum of congenital defects encountered with exposure to misoprostol included defects of the central nervous, musculoskeletal, urogenital and cardiovascular systems, in agreement with literature data.


CONCLUSIONS
the findings of this study suggest that fetuses exposed to misoprostol tend to be at higher risk of developing congenital malformations in comparison to non-exposed fetuses. Other studies should be encouraged for a better identification of the damage caused by the improper use of misoprostol, especially in countries where the control of medication is inadequate.
Opaleye
Emérita Sátiro
ES
Faculdade de Farmácia, Odontologia e Enfermagem, Universidade Federal do Ceará, Fortaleza, CE, Brasil.
Coelho
Helena Lutéscia Luna
HL
Schüler-Faccini
Lavínia
L
de Almeida
Paulo César
PC
dos Santos
Elaine Cavalcante
EC
Ribeiro
Ana Júlia Velozo
AJ
Costa
Fabrício da Silva
Fda S
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D000020:Abortifacient Agents, Nonsteroidal / Q000009:adverse effects*; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D016595:Misoprostol / Q000009:adverse effects*; D011247:Pregnancy; D018570:Risk Assessment
D000020:Abortifacient Agents, Nonsteroidal; D016595:Misoprostol