Pregnancy outcome after exposure to misoprostol in Brazil: A prospective, controlled study

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dc.contributor.authorSchuler, L.
dc.contributor.authorPastuszak, A.
dc.contributor.authorSanseverino, MTV
dc.contributor.authorOrioli, I. M.
dc.contributor.authorBrunoni, D.
dc.contributor.authorAshton-Prolla, P.
dc.contributor.authorCosta, F. S. da
dc.contributor.authorGiugliani, R.
dc.contributor.authorCouto, A. M.
dc.contributor.authorBrandao, S. B.
dc.contributor.authorKoren, G.
dc.contributor.institutionHosp Sick Children
dc.contributor.institutionUniv Fed Rio Grande Sul
dc.contributor.institutionClin Hosp
dc.contributor.institutionUniversidade Federal do Rio de Janeiro (UFRJ)
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionUniv Toronto
dc.date.accessioned2016-01-24T12:30:46Z
dc.date.available2016-01-24T12:30:46Z
dc.date.issued1999-03-01
dc.description.abstractBackground: Misoprostol, a synthetic prostaglandin E1 analog is labeled for the treatment of gastric and duodenal ulcers, in Brazil, where abortion is not a legal procedure, there is a widespread popular misuse of this drug in abortion attempts. This misuse and the fact that, in many cases the desired pregnancy termination does not occur, raise concerns about fetal safety. Case reports of congenital anomalies after maternal use of misoprostol have been published. the objective of this work was to compare pregnancy outcome following misoprostol exposure with a matched control group, This is the first prospective controlled study on fetal safety after misoprostol use. Methods: A prospective, observational cohort study with 86 exposed and 86 pair-matched, non-exposed controls. Results: There was no significant difference in the rates of major or minor birth between exposed compared to non-exposed infants (2/67 vs 2/81, major defects; 7/67 vs. 3/81, minor anomalies) There were significantly more miscarriages in the exposed group (17.1% vs, 5.8%; relative risk, 2.97; 95% confidence interval, 1.12 to 7.88), There was no statistical difference in gestational age at delivery, birth weight, sex ratio, rate of prematurity, low birth weight, or rates of cesarean section between groups. Conclusions: Our study, despite its limited statistical power, does not suggest a potent teratogenic action of misoprostol exposure during pregnancy. (C) 1999 Elsevier Science Inc.en
dc.description.affiliationHosp Sick Children, Div Clin Pharmacol Toxicol, Motherisk Program, Toronto, ON M5G 1X8, Canada
dc.description.affiliationUniv Fed Rio Grande Sul, Dept Genet, BR-90046900 Porto Alegre, RS, Brazil
dc.description.affiliationClin Hosp, Genet Serv, Brazilian Teratol Informat Serv, Porto Alegre, RS, Brazil
dc.description.affiliationUniv Fed Rio de Janeiro, Dept Genet, BR-21941 Rio de Janeiro, Brazil
dc.description.affiliationEscola Paulista Med, Genet Discipline, BR-04023 São Paulo, Brazil
dc.description.affiliationUniv Toronto, Fetal Diag & Treatment Ctr, Toronto, ON, Canada
dc.description.affiliationUnifespEscola Paulista Med, Genet Discipline, BR-04023 São Paulo, Brazil
dc.description.sourceWeb of Science
dc.format.extent147-151
dc.identifierhttp://dx.doi.org/10.1016/S0890-6238(98)00072-0
dc.identifier.citationReproductive Toxicology. Oxford: Pergamon-Elsevier B.V., v. 13, n. 2, p. 147-151, 1999.
dc.identifier.doi10.1016/S0890-6238(98)00072-0
dc.identifier.issn0890-6238
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/26043
dc.identifier.wosWOS:000079524300008
dc.language.isoeng
dc.publisherElsevier B.V.
dc.relation.ispartofReproductive Toxicology
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.licensehttp://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dc.subjectmisoprostolen
dc.subjectpregnancy complicationsen
dc.subjectabnormalitiesen
dc.subjectdrug induceden
dc.titlePregnancy outcome after exposure to misoprostol in Brazil: A prospective, controlled studyen
dc.typeinfo:eu-repo/semantics/article
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