Pregnancies and their results in phase III and IV clinical trial participants in Peru
Descripción del Articulo
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...
| Autores: | , , , |
|---|---|
| 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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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 |
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Revistas - Universidad Peruana Cayetano Heredia |
| collection |
Revistas - Universidad Peruana Cayetano Heredia |
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1846152843056119808 |
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12.884314 |
Nota importante:
La información contenida en este registro es de entera responsabilidad de la institución que gestiona el repositorio institucional donde esta contenido este documento o set de datos. El CONCYTEC no se hace responsable por los contenidos (publicaciones y/o datos) accesibles a través del Repositorio Nacional Digital de Ciencia, Tecnología e Innovación de Acceso Abierto (ALICIA).
La información contenida en este registro es de entera responsabilidad de la institución que gestiona el repositorio institucional donde esta contenido este documento o set de datos. El CONCYTEC no se hace responsable por los contenidos (publicaciones y/o datos) accesibles a través del Repositorio Nacional Digital de Ciencia, Tecnología e Innovación de Acceso Abierto (ALICIA).
