AI Article Synopsis
- The Division of Microbiology and Infectious Diseases at the NIH held conferences focused on including pregnant women in clinical trials for vaccines and therapeutics.
- Experts from various medical fields collaborated to establish normal ranges for vital signs and lab assessments during pregnancy.
- A grading system for evaluating adverse events in these trials was also created to enhance safety assessments for pregnant participants.
Article Abstract
The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss enrollment and safety assessments of pregnant women in clinical trials of vaccines. Experts in obstetrics, maternal-fetal medicine, infectious diseases, pediatrics, neonatology, genetics, vaccinology and clinical trial design were charged with identifying normal ranges for vital signs and laboratory assessments in pregnancy. A grading system for adverse events was then developed.
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| http://dx.doi.org/10.1016/j.vaccine.2013.07.031 | DOI Listing |
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