Obstetrics and gynecology
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Obstetrics and gynecology · May 2020
Accelerated Approval of 17α-Hydroxyprogesterone Caproate: A Cautionary Tale.
Before 2011, 17α-hydroxyprogesterone caproate (17P) was used to prevent recurrent preterm birth in women with singleton pregnancies and was compounded at a low cost (∼$15 per injection). In 2011, the U. S. ⋯ Trial completion triggered an automatic review of Makena by an advisory committee, which voted 9-7 to recommend revoking approval of Makena for preterm birth. Although the FDA created the Accelerated Approval Program to introduce therapies for serious conditions that lacked treatment options, Makena is an example of the limitations of this program. We encourage the FDA to re-evaluate their program and consider improvements, such as shorter timeframes to complete confirmatory trials, potentially revoking approval if the studies are not completed within a predefined timeframe, and to hold manufacturers responsible, in part, for the costs of therapy if they cannot prove a clinical benefit.
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Obstetrics and gynecology · Apr 2020
EditorialThe Urgent Need for Hepatitis C Screening in Pregnant Women: A Call to Action.
Hepatitis C virus (HCV) infection affects 170 million people worldwide, with at least 5% of individuals with HCV progressing to life-threatening complications, including hepatocellular carcinoma, within 20 years from acute infection. The World Health Organization has called for viral hepatitis elimination as a major public health threat by 2030. The recent development and availability of direct-acting antiviral drugs have been a game-changer in the HCV-treatment paradigm-response exceeds 90%, with minimal adverse events. ⋯ S. Preventive Services Task Force-recommended screening changes for all adults aged 18-79 years. We also review the current screening paradigm and treatment options for pregnant women and their children.
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Obstetrics and gynecology · Apr 2020
Clinical TrialPlasma Concentrations of Tranexamic Acid in Postpartum Women After Oral Administration.
To evaluate the pharmacokinetics of tranexamic acid after oral administration to postpartum women. ⋯ Clinically effective plasma concentrations of tranexamic acid in postpartum women may be achieved within 1 hour of oral administration. Given the promising pharmacokinetic properties, we recommend additional studies with larger sample sizes to investigate the potential of oral tranexamic acid for the treatment or prophylaxis of postpartum hemorrhage.
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Obstetrics and gynecology · Apr 2020
Adverse Infant and Maternal Outcomes Among Low-Risk Term Pregnancies Stratified by Race and Ethnicity.
To assess whether racial and ethnic disparities in adverse infant and maternal outcomes exist among low-risk term pregnancies. ⋯ Among low-risk term pregnancies, the risk for adverse outcomes varied by maternal race and ethnicity. Infants of black women were at the highest risk for neonatal morbidity and infant mortality, and Asian mothers were most likely to experience maternal adverse outcomes.
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Obstetrics and gynecology · Apr 2020
Universal Screening and Vaccination for Hepatitis B in Pregnancy: The Time Is Now.
Recommendations for screening for hepatitis B immunity in pregnancy and vaccinating susceptible women vary among professional societies. The American College of Obstetricians and Gynecologists recommends vaccinating high-risk women for hepatitis B. However, only one fourth of U. ⋯ Hepatitis B vaccination in pregnancy is safe and efficacious and can be completed during the course of prenatal care. Universal screening for hepatitis B immunity and vaccination of susceptible women in pregnancy should be a priority during prenatal care. Cost-effectiveness studies are needed to validate this approach.