Effectiveness and Harms of 17-α Hydroxyprogesterone Caproate (Makena) to Prevent Preterm Birth Report

Approximately 10% of live births occur preterm, or before 37 weeks of gestation, and are at a higher risk of neonatal morbidity and mortality than full-term births. Medicaid programs pay for about half of preterm births (PTB) in the U.S., and Medicaid administrators are interested in the effectiveness and harms of 17-alpha hydroxyprogesterone caproate (17P; brand name Makena) to prevent recurrent PTB in women with singleton pregnancies and a prior spontaneous PTB. In this report, Center researchers synthesized evidence from 7 randomized controlled trials (RCTs) that compared the effectiveness of 17P to vaginal progesterone, placebo, or treatment as usual; this synthesis includes results from the largest-to-date placebo-controlled RCT testing the effectiveness of 17P to prevent recurrent PTB. The key questions in this report address effectiveness, harms, and ongoing RCTs testing the effectiveness of 17P for women with singleton pregnancies and a history of spontaneous PTB.

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