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

Authors

  • Christian Palomino Flores
  • Elisa Mamani Mamani
  • Rocío Victoria Hermoza- Moquillaza
  • Jenny Parillo Flores

DOI:

https://doi.org/10.20453/rmh.v31i1.3722

Keywords:

Pregnancy; Phase III clinical trials as a matter; Phase IV clinical trials as a matter; safety

Abstract

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. 

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Published

2020-04-29

How to Cite

1.
Palomino Flores C, Mamani Mamani E, Hermoza- Moquillaza RV, Parillo Flores J. Pregnancies and their results in phase III and IV clinical trial participants in Peru. Rev Méd Hered [Internet]. 2020 Apr. 29 [cited 2024 Apr. 23];31(1):12-6. Available from: https://revistas.upch.edu.pe/index.php/RMH/article/view/3722

Issue

Vol. 31 No. 1 (2020): January - March

Section

ORIGINAL RESEARCH

License

Authors assign their rights to the RMH so that may disseminate the article through the means at their disposal. The journal will provide forms of affidavit of authorship and authorization for the publication of the article, which shall be submitted with the manuscript. Authors retain the right to share, copy, distribute, perform and publicly communicate their article, or part of it, mentioning the original publication in the journal.