A chronicle of the 17-alpha hydroxyprogesterone caproate story to prevent recurrent preterm birth

• Published in: American journal of obstetrics and gynecology Vol. 224; no. 2; pp. 175 - 186
• Main Authors: Nelson, David B., McIntire, Donald D., Leveno, Kenneth J.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2021
• Subjects: 17 alpha-Hydroxyprogesterone Caproate - therapeutic use; 17-alpha hydroxyprogesterone caproate; accelerated approval; Drug and Narcotic Control; Drug Approval; Evidence-Based Medicine; Female; Food and Drug Administration; healthcare cost; Humans; Observational Studies as Topic; pharmaceutical industry; Pregnancy; Premature Birth - prevention & control; preterm labor; progesterone; progestin; Progestins - therapeutic use; progestogen; randomized clinical trial; Randomized Controlled Trials as Topic; real-world evidence; Recurrence; regulatory process; subgroup analysis; United States; United States Food and Drug Administration; withdrawal; United States; pharmaceutical industry; progestin; real-world evidence; subgroup analysis; pregnancy; progesterone; preterm labor; randomized clinical trial; withdrawal; healthcare cost; regulatory process; accelerated approval; progestogen; 17-alpha hydroxyprogesterone caproate; evidence-based medicine; Food and Drug Administration

Preterm birth is a substantial public health concern. In 2019, the US preterm birth rate was 10.23%, which is the fifth straight year of increase in this rate. Moreover, preterm birth accounts for approximately 1 in 6 infant deaths, and surviving children often suffer developmental delay or long-ter...