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SMFM Consult Series #70: Management of short cervix in individuals without a history of spontaneous preterm birth.
Am J Obstet Gynecol
August 2024
Most deliveries before 34 weeks of gestation occur in individuals with no previous history of preterm birth. Midtrimester cervical length assessment using transvaginal ultrasound is one of the best clinical predictors of spontaneous preterm birth. This Consult provides guidance for the diagnosis and management of a short cervix in an individual without a history of preterm birth.
View Article and Find Full Text PDFThe dosing regimen for 17-hydroxyprogesterone caproate was suboptimal: lessons for future pharmacotherapy for pregnant women.
Am J Obstet Gynecol
January 2025
Departments of Pharmaceutical Sciences and Pathology, University of Pittsburgh School of Pharmacy, Pittsburgh, PA; Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Background: Makena (17-hydroxyprogesterone caproate) was approved by the United States Food and Drug Administration for the prevention of recurrent spontaneous preterm birth in 2011 under the accelerated approval pathway, but fundamental pharmacokinetic or pharmacodynamic (Phase 1 and Phase 2) studies were not performed. At the time, there were no dose-response or concentration-response data. The therapeutic concentration was not known.
View Article and Find Full Text PDFOn April 5, 2023, the US Food and Drug Administration withdrew the approval of 17-alpha hydroxyprogesterone caproate, effective immediately, because of the lack of evidence that it reduces the risk of recurrent spontaneous preterm birth. This decision withdraws approval for all formulations of 17-alpha hydroxyprogesterone caproate (both intramuscular and subcutaneous) and applies to both brand name (Makena) and generic versions of the medication. We agree with the Food and Drug Administration determination and discourage continued prescribing of 17-alpha hydroxyprogesterone caproate, including through compounding pharmacies.
View Article and Find Full Text PDFEligibility, Utilization, and Effectiveness of 17-Alpha Hydroxyprogesterone Caproate in a Statewide Population-Based Cohort of Medicaid Enrollees.
Am J Perinatol
December 2023
PolicyLab, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Objective: The primary objective was to estimate the initiation and adherence rates of 17 α-hydroxyprogesterone caproate (17OHPC) among eligible mothers in a statewide population-based cohort of Medicaid enrollees. The secondary objectives were to (1) determine the association of maternal sociodemographic and clinical characteristics with 17OHPC utilization and (2) assess the real-world effectiveness of 17OHPC on recurrent preterm birth prevention and admission to neonatal intensive care unit (NICU).
Study Design: This is a retrospective cohort study using a linked, longitudinal administrative dataset of birth certificates and medical assistance claims.
Utilization of hydroxyprogesterone caproate among pregnancies with live birth deliveries in the sentinel distributed database.
J Matern Fetal Neonatal Med
December 2022
Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Background: The U.S. Food and Drug Administration (FDA) approved Makena (hydroxyprogesterone caproate [HPC] injection) in February 2011 for reducing the risk of preterm birth (PTB) in women with a singleton pregnancy who had a history of singleton spontaneous PTB (sPTB).
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