Pregnancies and their results in phase III and IV clinical trial participants in Peru

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Objectives: To identify the occurrence of cases of pregnancy, births and abortion in participants of clinical trials in phases III and IV, in Peru. Methods: Retrospective secondary data analysis study of all cases of pregnancy that occurred during clinical trials, in the period 2010 to 2015. The dat...

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Detalles Bibliográficos
Autores: Palomino Flores, Christian, Mamani Mamani, Elisa, Hermoza- Moquillaza, Rocío Victoria, Parillo Flores, Jenny
Formato: artículo
Fecha de Publicación:2020
Institución:Universidad Peruana Cayetano Heredia
Repositorio:Revistas - Universidad Peruana Cayetano Heredia
Lenguaje:español
OAI Identifier:oai:revistas.upch.edu.pe:article/3722
Enlace del recurso:https://revistas.upch.edu.pe/index.php/RMH/article/view/3722
Nivel de acceso:acceso abierto
Materia:Embarazo; ensayos clínicos Fase III como asunto; ensayos clínicos Fase IV como asunto; seguridad
Pregnancy; Phase III clinical trials as a matter; Phase IV clinical trials as a matter; safety
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spelling Pregnancies and their results in phase III and IV clinical trial participants in PeruEmbarazos y sus resultados en las participantes de ensayos clínicos de fase III y IV en el PerúPalomino Flores, ChristianMamani Mamani, ElisaHermoza- Moquillaza, Rocío VictoriaParillo Flores, JennyEmbarazo; ensayos clínicos Fase III como asunto; ensayos clínicos Fase IV como asunto; seguridadPregnancy; Phase III clinical trials as a matter; Phase IV clinical trials as a matter; safetyObjectives: To identify the occurrence of cases of pregnancy, births and abortion in participants of clinical trials in phases III and IV, in Peru. Methods: Retrospective secondary data analysis study of all cases of pregnancy that occurred during clinical trials, in the period 2010 to 2015. The data were obtained from the virtual system REAS-NET, of the National Institute of Health for the report of serious adverse events. The Fisher and Chi square test was used to analyze the variables. Results: 30 cases of pregnancies of patients enrolled in clinical trials were found, 24 of them in phase III trials. The age range was 19 to 44 years, 21 cases ended in abortion. None of the variables studied presented a significant association with the outcome of pregnancy: abortion and normal live birth. Conclusions: Pregnancies were found in the participants in phase III and IV clinical trials, the age corresponded to the fertile age of the women. Objetivos: Identificar la ocurrencia de casos de embarazo, nacimientos y aborto en participantes de ensayos clínicos en fases III y IV, en Perú. Material y métodos: Estudio de análisis de datos secundarios, retrospectivo, de todos los casos de embarazo ocurridos durante la realización de ensayos clínicos, en el periodo 2010 al 2015. Los datos se obtuvieron del sistema virtual REAS-NET, del Instituto Nacional de Salud para el reporte de eventos adversos serios. Se utilizó la prueba de Fisher y Chi cuadrado para el análisis de las variables Resultados: Se encontraron 30 casos de embarazos de pacientes enroladas en los ensayos clínicos, 24 de ellos en ensayos de fase III. El rango de edad fue 19 a 44 años, 21 casos terminaron en aborto. Ninguna de las variables estudiadas presentó asociación significativa con el resultado del embarazo: aborto y nacido vivo normal. Conclusiones: Se encontraron embarazos en las participantes en ensayos clínicos de fase III y IV, la edad correspondió a la edad fértil de las mujeres. Universidad Peruana Cayetano Heredia2020-04-29info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionPeer-reviewed articleArtículo evaluado por paresapplication/pdfhttps://revistas.upch.edu.pe/index.php/RMH/article/view/372210.20453/rmh.v31i1.3722Revista Médica Herediana; Vol. 31 No. 1 (2020): January - March; 12-16Revista Médica Herediana; Vol. 31 Núm. 1 (2020): Enero - Marzo; 12-16Revista Medica Herediana; v. 31 n. 1 (2020): Enero - Marzo; 12-161729-214X1018-130Xreponame:Revistas - Universidad Peruana Cayetano Herediainstname:Universidad Peruana Cayetano Herediainstacron:UPCHspahttps://revistas.upch.edu.pe/index.php/RMH/article/view/3722/4134info:eu-repo/semantics/openAccessoai:revistas.upch.edu.pe:article/37222020-06-17T16:01:37Z
dc.title.none.fl_str_mv Pregnancies and their results in phase III and IV clinical trial participants in Peru
Embarazos y sus resultados en las participantes de ensayos clínicos de fase III y IV en el Perú
title Pregnancies and their results in phase III and IV clinical trial participants in Peru
spellingShingle Pregnancies and their results in phase III and IV clinical trial participants in Peru
Palomino Flores, Christian
Embarazo; ensayos clínicos Fase III como asunto; ensayos clínicos Fase IV como asunto; seguridad
Pregnancy; Phase III clinical trials as a matter; Phase IV clinical trials as a matter; safety
title_short Pregnancies and their results in phase III and IV clinical trial participants in Peru
title_full Pregnancies and their results in phase III and IV clinical trial participants in Peru
title_fullStr Pregnancies and their results in phase III and IV clinical trial participants in Peru
title_full_unstemmed Pregnancies and their results in phase III and IV clinical trial participants in Peru
title_sort Pregnancies and their results in phase III and IV clinical trial participants in Peru
dc.creator.none.fl_str_mv Palomino Flores, Christian
Mamani Mamani, Elisa
Hermoza- Moquillaza, Rocío Victoria
Parillo Flores, Jenny
author Palomino Flores, Christian
author_facet Palomino Flores, Christian
Mamani Mamani, Elisa
Hermoza- Moquillaza, Rocío Victoria
Parillo Flores, Jenny
author_role author
author2 Mamani Mamani, Elisa
Hermoza- Moquillaza, Rocío Victoria
Parillo Flores, Jenny
author2_role author
author
author
dc.subject.none.fl_str_mv Embarazo; ensayos clínicos Fase III como asunto; ensayos clínicos Fase IV como asunto; seguridad
Pregnancy; Phase III clinical trials as a matter; Phase IV clinical trials as a matter; safety
topic Embarazo; ensayos clínicos Fase III como asunto; ensayos clínicos Fase IV como asunto; seguridad
Pregnancy; Phase III clinical trials as a matter; Phase IV clinical trials as a matter; safety
description Objectives: To identify the occurrence of cases of pregnancy, births and abortion in participants of clinical trials in phases III and IV, in Peru. Methods: Retrospective secondary data analysis study of all cases of pregnancy that occurred during clinical trials, in the period 2010 to 2015. The data were obtained from the virtual system REAS-NET, of the National Institute of Health for the report of serious adverse events. The Fisher and Chi square test was used to analyze the variables. Results: 30 cases of pregnancies of patients enrolled in clinical trials were found, 24 of them in phase III trials. The age range was 19 to 44 years, 21 cases ended in abortion. None of the variables studied presented a significant association with the outcome of pregnancy: abortion and normal live birth. Conclusions: Pregnancies were found in the participants in phase III and IV clinical trials, the age corresponded to the fertile age of the women. 
publishDate 2020
dc.date.none.fl_str_mv 2020-04-29
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
Peer-reviewed article
Artículo evaluado por pares
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://revistas.upch.edu.pe/index.php/RMH/article/view/3722
10.20453/rmh.v31i1.3722
url https://revistas.upch.edu.pe/index.php/RMH/article/view/3722
identifier_str_mv 10.20453/rmh.v31i1.3722
dc.language.none.fl_str_mv spa
language spa
dc.relation.none.fl_str_mv https://revistas.upch.edu.pe/index.php/RMH/article/view/3722/4134
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidad Peruana Cayetano Heredia
publisher.none.fl_str_mv Universidad Peruana Cayetano Heredia
dc.source.none.fl_str_mv Revista Médica Herediana; Vol. 31 No. 1 (2020): January - March; 12-16
Revista Médica Herediana; Vol. 31 Núm. 1 (2020): Enero - Marzo; 12-16
Revista Medica Herediana; v. 31 n. 1 (2020): Enero - Marzo; 12-16
1729-214X
1018-130X
reponame:Revistas - Universidad Peruana Cayetano Heredia
instname:Universidad Peruana Cayetano Heredia
instacron:UPCH
instname_str Universidad Peruana Cayetano Heredia
instacron_str UPCH
institution UPCH
reponame_str Revistas - Universidad Peruana Cayetano Heredia
collection Revistas - Universidad Peruana Cayetano Heredia
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 12.773104
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