American journal of obstetrics and gynecology
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Am. J. Obstet. Gynecol. · Sep 2012
ReviewInfluenza immunization during pregnancy: US regulatory perspective.
Maternal immunization with inactivated influenza vaccines is an important public health strategy to protect mothers and young infants from the serious complications of influenza. Although not contraindicated in pregnant women, currently US-licensed influenza vaccines are not specifically labeled for use during pregnancy. ⋯ The Food and Drug Administration is revising its pregnancy labeling regulations to improve the characterization and communication of risks of drugs and biologics used during pregnancy. To obtain a specifically labeled indication for use of an influenza vaccine during pregnancy, adequate and well-controlled prelicensure studies are needed to obtain data on the product's safety and effectiveness and to demonstrate protection of the mother and/or infant against influenza illness.
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Prevention of influenza in pregnant women and their newborns through maternal immunization is a safe and effective intervention during seasonal epidemics and a priority during a pandemic. While influenza vaccination of pregnant women has been routine in the United States since the 1950s, coverage rates increased significantly only after the 2009 H1N1 influenza pandemic. Epidemiologic and clinical studies support the safety of inactivated influenza vaccines in pregnant women and their infants. Safety barriers to the use of vaccines during pregnancy can be addressed through research, active surveillance, and education.
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Am. J. Obstet. Gynecol. · Sep 2012
Comparative StudyComparison of 12-hour urine protein and protein:creatinine ratio with 24-hour urine protein for the diagnosis of preeclampsia.
The purpose of this study was to evaluate the performance of the 12-hour urine protein >165 mg and protein:creatinine ratio >0.15 for the prediction of 24-hour urine protein of ≥300 mg in patients with suspected preeclampsia. ⋯ The high correlation of a 12-hour urine protein >165 mg with a 24-hour urine protein ≥300 mg (with the benefit of a shorter evaluation time) and the high negative predictive value of protein:creatinine ratio suggest that the use of both these tests have a role in the evaluation and treatment of women with suspected preeclampsia.
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Am. J. Obstet. Gynecol. · Sep 2012
ReviewAssessing the safety of influenza immunization during pregnancy: the Vaccine Safety Datalink.
The influenza vaccine can reduce maternal and neonatal morbidity and mortality and thus is recommended for all pregnant women. However, concerns regarding safety of influenza vaccine remain a barrier to vaccination. We describe ongoing analyses of influenza vaccine safety during pregnancy within the Vaccine Safety Datalink that includes the evaluation of acute events, adverse pregnancy and birth outcomes, and congenital anomalies. In addition, we highlight unique challenges and strategies for the study of vaccine safety among pregnant women with the use of large linked databases.
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Am. J. Obstet. Gynecol. · Sep 2012
ReviewSafety of influenza immunization during pregnancy for the fetus and the neonate.
Since the 1960s, pregnant women in the United States have been recommended to receive influenza vaccine. A maternal concern about the possibility of adverse fetal and neonatal outcomes after the vaccination of pregnant women has been cited as a reason for low maternal influenza vaccination coverage. ⋯ This review summarizes nearly 40 years of research on influenza vaccination of pregnant women and the lack of association with adverse fetal or neonatal outcomes. Future research should focus on vaccinations that are given in the first trimester of pregnancy and on product-specific analyses to account for differences in manufacturing processes.