title: Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments.
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.
authors.affiliation: Department of Obstetrics and Gynecology, Division Maternal-Fetal Medicine, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA. jeanne.sheffield@utsouthwestern.edu
authors.forename: Jeanne S
authors.initials: JS
authors.lastname: Sheffield
authors.forename: Flor M
authors.initials: FM
authors.lastname: Munoz
authors.forename: Richard H
authors.initials: RH
authors.lastname: Beigi
authors.forename: Sonja A
authors.initials: SA
authors.lastname: Rasmussen
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Edwards
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Read
authors.forename: R Phillips
authors.initials: RP
authors.lastname: Heine
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Ault
authors.forename: Geeta K
authors.initials: GK
authors.lastname: Swamy
authors.forename: Indira
authors.initials: I
authors.lastname: Jevaji
authors.forename: Catherine Y
authors.initials: CY
authors.lastname: Spong
authors.forename: Kimberly B
authors.initials: KB
authors.lastname: Fortner
authors.forename: Shital M
authors.initials: SM
authors.lastname: Patel
authors.forename: Mirjana
authors.initials: M
authors.lastname: Nesin
mesh_terms: D001774:Blood Chemical Analysis; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000517:prevention & control; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control; D012016:Reference Values; D014611:Vaccination / Q000009:adverse effects*; D014612:Vaccines / Q000009:adverse effects* / Q000627:therapeutic use*
chemical_list: D014612:Vaccines
keywords: Laboratory assessment; Maternal immunization; Toxicity grading scale