A Randomized Trial of 17 ?-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in High Risk Women

The primary objective of the Progesterone randomized trial was to determine whether 17 alpha-hydroxyprogesterone caproate (17P) reduced the risk of preterm birth in people who had a previous early spontaneous preterm birth. Participants were enrolled at 16 to 20 weeks of gestation and randomly assigned in a 2:1 ratio to receive either weekly injections of 250 mg of 17P or weekly injections of a placebo. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation. Infants of people treated with 17P had lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen. A follow-up study of the children from the trial was conducted to determine whether there were differences in achievement of developmental milestones between treatment groups. No significant differences were seen in health status or physical examination. Scores for Preschool Activities Inventory were within the normal range and similar between groups.