Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle

Detalhes bibliográficos
Autor(a) principal: Opaleye, Emérita Sátiro
Data de Publicação: 2006
Tipo de documento: Dissertação
Idioma: por
Título da fonte: Repositório Institucional da Universidade Federal do Ceará (UFC)
Texto Completo: http://www.repositorio.ufc.br/handle/riufc/4214
Resumo: Misoprostol (Cytotec®) is a prostaglandin E1 analog, previously commercialized with therapeutic purposes, with proscribed use in the gravid due to the risk of miscarriage. The common practice of abortion and the inefficient control on access to drugs in our country has lead to the generalized use of this drug as an abortive method. Studies have shown that the abortive potency of misoprostol is variable and its use without medical assistance may lead to thriving gestation, and a consequent risk of malformation to the fetus. Various case reports and epidemiological studies associate the use of misoprostol during gestation with offspring bearing malformations, especially with the Möebius sequence, terminal transverse-limb defects and diverse other anomalies of the central nervous system. The risk of acquiring these malformations cannot however be determined with available data, thus, there is a need for continuous research. OBJECTIVE: Identifying newborns bearing malformations in the leading maternities in Fortaleza and selecting their respective study controls, determining the frequency of exposition to misoprostol and identifying the spectrum of anomalies in the exposed group. METHODS: A case control-study, with a daily active search within the four largest maternities in Fortaleza, Ceara for newborn with congenital defects and a paired control, from July to November 2005. Every mother was interviewed with a questionnaire in the search for diverse expositions during pregnancy, including misoprostol. RESULTS: The groups were homogenous in respect to their socioeconomic profile and other main characteristics. Differences were found in respect to unfavorable outcomes among newborn with congenital defects like low weight (p=0,0001), low weight in relation to gestational age (p=0,006), increased natimortality (p=0,024) and increased perinatal mortality (p=0,0001). Both groups had adequate pre-natal assistance (69%), deferring only in the amount of ultrasonographic exams carried out in the case group (p=0,003). In regards to risk factors, the only deference encountered was the case group having more breech presentation (19,8%, p=0,037). Approximately 84% of mothers had been exposed to at least one medication during gestation, and the average number of drugs consumed was 3, 72. The use of tobacco, alcohol and illicit drugs was rarely informed, and only tobacco smoking was more frequent in the control group (p=0,0171). Most gestation were reported as planed or desired (70% of the total). Attempted abortion was reported in 6,8% of whole sample, with the use of misoprostol in the case group, although without statistic significance. CONCLUSION: The findings of these study suggest that exposition to misoprostol during gestation occurs more frequently in newborn with congenital defects compared with healthy ones, Odds Ratio (OR) = 3,65 [IC95%: 0,74;17,91]. The spectrum of malformations found and associated with misoprostol was hydrocephalus, meningomyelocele, agenesis of hip, equinovarus, luxation of the knee, hip congenital dislocation, absence of distal phalanges, syndactyly, polidactyly, anal imperforation, criptorchidism and cystic higroma.
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spelling Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controleEvaluation of the teratogenic risks em gestations exposed to misoprostol : a case-control studyDesenvolvimento FetalAbortivosMisoprostol (Cytotec®) is a prostaglandin E1 analog, previously commercialized with therapeutic purposes, with proscribed use in the gravid due to the risk of miscarriage. The common practice of abortion and the inefficient control on access to drugs in our country has lead to the generalized use of this drug as an abortive method. Studies have shown that the abortive potency of misoprostol is variable and its use without medical assistance may lead to thriving gestation, and a consequent risk of malformation to the fetus. Various case reports and epidemiological studies associate the use of misoprostol during gestation with offspring bearing malformations, especially with the Möebius sequence, terminal transverse-limb defects and diverse other anomalies of the central nervous system. The risk of acquiring these malformations cannot however be determined with available data, thus, there is a need for continuous research. OBJECTIVE: Identifying newborns bearing malformations in the leading maternities in Fortaleza and selecting their respective study controls, determining the frequency of exposition to misoprostol and identifying the spectrum of anomalies in the exposed group. METHODS: A case control-study, with a daily active search within the four largest maternities in Fortaleza, Ceara for newborn with congenital defects and a paired control, from July to November 2005. Every mother was interviewed with a questionnaire in the search for diverse expositions during pregnancy, including misoprostol. RESULTS: The groups were homogenous in respect to their socioeconomic profile and other main characteristics. Differences were found in respect to unfavorable outcomes among newborn with congenital defects like low weight (p=0,0001), low weight in relation to gestational age (p=0,006), increased natimortality (p=0,024) and increased perinatal mortality (p=0,0001). Both groups had adequate pre-natal assistance (69%), deferring only in the amount of ultrasonographic exams carried out in the case group (p=0,003). In regards to risk factors, the only deference encountered was the case group having more breech presentation (19,8%, p=0,037). Approximately 84% of mothers had been exposed to at least one medication during gestation, and the average number of drugs consumed was 3, 72. The use of tobacco, alcohol and illicit drugs was rarely informed, and only tobacco smoking was more frequent in the control group (p=0,0171). Most gestation were reported as planed or desired (70% of the total). Attempted abortion was reported in 6,8% of whole sample, with the use of misoprostol in the case group, although without statistic significance. CONCLUSION: The findings of these study suggest that exposition to misoprostol during gestation occurs more frequently in newborn with congenital defects compared with healthy ones, Odds Ratio (OR) = 3,65 [IC95%: 0,74;17,91]. The spectrum of malformations found and associated with misoprostol was hydrocephalus, meningomyelocele, agenesis of hip, equinovarus, luxation of the knee, hip congenital dislocation, absence of distal phalanges, syndactyly, polidactyly, anal imperforation, criptorchidism and cystic higroma.O misoprostol (Cytotec®) é um análogo de prostaglandina E1, inicialmente comercializado com finalidades terapêuticas do trato gastrintestinal, de uso proscrito em gestantes pelo risco de abortamento. A realidade do aborto e o ineficiente controle de medicamentos em nosso país tornaram generalizado seu uso como método abortivo. Estudos demonstram que o potencial abortivo do misoprostol é variável e seu uso sem acompanhamento médico pode levar a uma gestação que não se perde, gerando risco para o embrião/feto. Vários relatos de casos e estudos epidemiológicos associam o uso de misoprostol durante a gestação com crianças malformadas, especialmente seqüência de Möebius, defeitos de redução de membros e diversas anomalias do sistema nervoso central. O risco do surgimento destes defeitos não pôde ainda ser determinado com os dados atualmente disponíveis, fazendo-se necessário a continuidade de pesquisas. OBJETIVOS: Identificar em recém nascidos (RNs) malformados nas principais maternidades de Fortaleza e em controles normais a freqüência de exposição ao misoprostol e apresentar o espectro de MFs dos neonatos expostos. MÉTODOS: Estudo de caso controle, com busca ativa diária de RNs malformados e controles pareados em quatro maternidades públicas de Fortaleza – CE, no período de julho a novembro de 2005, para entrevista com a parturiente utilizando questionário estruturado, na busca por exposições diversas durante a gestação, inclusive ao misoprostol. RESULTADOS: Os grupos eram homogêneos quanto ao perfil sócio-demográfico e principais características, apresentando diferenças somente em desfechos desfavoráveis mais esperados em RNs MFs, como menor peso (p=0,0001), menor adequação peso x idade gestacional (p=0,006), maior natimortalidade (p=0,024) e maior mortalidade perinatal (p=0,0001). Ambos os grupos tiveram índice de assistência pré-natal no mínimo adequada (69%), diferindo somente na quantidade de ultra-sonografias (US) realizadas a mais pelos casos (p=0,003). Quanto aos fatores de risco, a única diferença consistiu no grupo caso ter apresentado maior freqüência em apresentação pélvica (19,8%, p=0,037). Aproximadamente 84% das mães relataram exposição a pelo menos um medicamento durante a gestação, e a média de medicamentos consumidos por gestante foi de 3,72. O uso de fumo, álcool e drogas ilícitas foi pouco reportado, e somente o fumo apresentou-se mais freqüente no grupo controle (p=0,0171). A maior parte das gestações foi declarada como planejada ou desejada (70% do total). O relato de tentativa de aborto foi de 6,8% do total da amostra, havendo maior citação de uso de misoprostol no grupo caso, embora não tenha sido estatisticamente significativo. CONCLUSÃO: Os achados deste estudo sugerem que ocorre uma maior exposição de misoprostol durante a gestação em RNs malformados comparados a RNs saudáveis, Odds Ratio (OR) = 3,65 [IC95%: 0,74;17,91]. O espectro de MFs encontradas, associadas ao misoprostol foi: hidrocefalia, mielomeningocele, agenesia de quadril, pé equinovaro, luxação de joelho, luxação de quadril, agenesia de falanges distais, sindactilia, polidactilia, imperfuração anal, ausência de testículos no bolso escrotal e higroma cístico.Costa , Fabricio da SilvaOpaleye, Emérita Sátiro2012-12-19T13:32:54Z2012-12-19T13:32:54Z2006info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfOPALEYE, E. S. Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle . 2006. 162 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal do Ceará. Faculdade de Farmácia, Odontologia e Enfermagem, Fortaleza, 2006.http://www.repositorio.ufc.br/handle/riufc/4214porreponame:Repositório Institucional da Universidade Federal do Ceará (UFC)instname:Universidade Federal do Ceará (UFC)instacron:UFCinfo:eu-repo/semantics/openAccess2018-12-28T13:11:59Zoai:repositorio.ufc.br:riufc/4214Repositório InstitucionalPUBhttp://www.repositorio.ufc.br/ri-oai/requestbu@ufc.br || repositorio@ufc.bropendoar:2024-09-11T18:51:51.828387Repositório Institucional da Universidade Federal do Ceará (UFC) - Universidade Federal do Ceará (UFC)false
dc.title.none.fl_str_mv Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle
Evaluation of the teratogenic risks em gestations exposed to misoprostol : a case-control study
title Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle
spellingShingle Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle
Opaleye, Emérita Sátiro
Desenvolvimento Fetal
Abortivos
title_short Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle
title_full Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle
title_fullStr Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle
title_full_unstemmed Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle
title_sort Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle
author Opaleye, Emérita Sátiro
author_facet Opaleye, Emérita Sátiro
author_role author
dc.contributor.none.fl_str_mv Costa , Fabricio da Silva
dc.contributor.author.fl_str_mv Opaleye, Emérita Sátiro
dc.subject.por.fl_str_mv Desenvolvimento Fetal
Abortivos
topic Desenvolvimento Fetal
Abortivos
description Misoprostol (Cytotec®) is a prostaglandin E1 analog, previously commercialized with therapeutic purposes, with proscribed use in the gravid due to the risk of miscarriage. The common practice of abortion and the inefficient control on access to drugs in our country has lead to the generalized use of this drug as an abortive method. Studies have shown that the abortive potency of misoprostol is variable and its use without medical assistance may lead to thriving gestation, and a consequent risk of malformation to the fetus. Various case reports and epidemiological studies associate the use of misoprostol during gestation with offspring bearing malformations, especially with the Möebius sequence, terminal transverse-limb defects and diverse other anomalies of the central nervous system. The risk of acquiring these malformations cannot however be determined with available data, thus, there is a need for continuous research. OBJECTIVE: Identifying newborns bearing malformations in the leading maternities in Fortaleza and selecting their respective study controls, determining the frequency of exposition to misoprostol and identifying the spectrum of anomalies in the exposed group. METHODS: A case control-study, with a daily active search within the four largest maternities in Fortaleza, Ceara for newborn with congenital defects and a paired control, from July to November 2005. Every mother was interviewed with a questionnaire in the search for diverse expositions during pregnancy, including misoprostol. RESULTS: The groups were homogenous in respect to their socioeconomic profile and other main characteristics. Differences were found in respect to unfavorable outcomes among newborn with congenital defects like low weight (p=0,0001), low weight in relation to gestational age (p=0,006), increased natimortality (p=0,024) and increased perinatal mortality (p=0,0001). Both groups had adequate pre-natal assistance (69%), deferring only in the amount of ultrasonographic exams carried out in the case group (p=0,003). In regards to risk factors, the only deference encountered was the case group having more breech presentation (19,8%, p=0,037). Approximately 84% of mothers had been exposed to at least one medication during gestation, and the average number of drugs consumed was 3, 72. The use of tobacco, alcohol and illicit drugs was rarely informed, and only tobacco smoking was more frequent in the control group (p=0,0171). Most gestation were reported as planed or desired (70% of the total). Attempted abortion was reported in 6,8% of whole sample, with the use of misoprostol in the case group, although without statistic significance. CONCLUSION: The findings of these study suggest that exposition to misoprostol during gestation occurs more frequently in newborn with congenital defects compared with healthy ones, Odds Ratio (OR) = 3,65 [IC95%: 0,74;17,91]. The spectrum of malformations found and associated with misoprostol was hydrocephalus, meningomyelocele, agenesis of hip, equinovarus, luxation of the knee, hip congenital dislocation, absence of distal phalanges, syndactyly, polidactyly, anal imperforation, criptorchidism and cystic higroma.
publishDate 2006
dc.date.none.fl_str_mv 2006
2012-12-19T13:32:54Z
2012-12-19T13:32:54Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/masterThesis
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dc.identifier.uri.fl_str_mv OPALEYE, E. S. Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle . 2006. 162 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal do Ceará. Faculdade de Farmácia, Odontologia e Enfermagem, Fortaleza, 2006.
http://www.repositorio.ufc.br/handle/riufc/4214
identifier_str_mv OPALEYE, E. S. Avaliação de riscos teratogênicos em gestações expostas ao misoprostol : um estudo de caso-controle . 2006. 162 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal do Ceará. Faculdade de Farmácia, Odontologia e Enfermagem, Fortaleza, 2006.
url http://www.repositorio.ufc.br/handle/riufc/4214
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