P-188: Vaginal Progesterone Effects for The Prevention of Preterm Birth and Neonatal Complications in Women at Increased Risk: A Randomized Placebo- Controlled Double-Blind Study

Background: The purpose of this study was to evaluate the effect of prophylactic vaginal progesterone in decreasing preterm birth rate and neonatal complications in a high-risk population. Materials and Methods: A randomized, double-blind, placebo- controlled study included 100 high-risk singleton pregnancies( prior preterm birth,short cervix,uterine malformations and large intramural uterine myomas).Vaginal suppository progesterone (400 mg) or placebo was administered daily between 16-22 weeks to36weeks of gestation. Progesterone (n=50) and placebo (n=50) groups were compared to incidence of preterm delivery and neonatal complications. Results: The preterm birth rate was 52% (52/100). There was a statistically significant difference in the rate of preterm labor between progestrone and placebo groups(36 vs. 68%.respectively; p=0.001). Preterm birth before 34 and 32 weeks of gestation was significantly more in the placebo group (42 and 34%, respectively; p=0.009) than in the progesterone group (18 and 8% respectively; p=0.001). Our study also showed that administration of vaginal progesterone suppositories was associated with a significant decrease in low birth weight(<2500 g),duration of hospitalization of neonates in neonatal care unit, and respiratory distress syndrome. However, we did not observe significant decrease in the other neonatal complications including neonatal death, intraventricular hemorrhage and necrotizing enterocolitis. Conclusion: Prophylactic vaginal progesterone reduced the rate of preterm delivery in women who were subject to high risk for preterm birth. It was also associated with a significant decrease in low birth weight(<2500 g),duration of hospitalization of neonates in neonatal care unit, and respiratory distress syndrome