Progesterone & Prevention of Preterm Delivery
Michael Paidas, M.D. Associate Professor Co-Director,The Yale Blood Center for Women and Children Department of Obstetrics, Gynecology & Reproductive Sciences Yale University School of Medicine Food and Drug Administration Advisory Committee for Reproductive Health Drugs August 29, 2006 1 Preterm Delivery PTD and Low birth weight represent the leading cause of infant mortality PTD Rate Over 12% in USA, and rising Cost: 13.6 billion dollars in 2001 No effective Treatment, but antenatal steroids will reduce prematurity complications Progesterone as a prevention 17- alpha-Hydroxyprogesterone (250mg) IM Weekly from wk reduces recurrent PTD (RCT Double blind, 2:1 ratio) Progesterone Group: N= 310Placebo: N= 153 Meis PJ et al, NEJM 2003; 348: Outcome Progesterone N= 306 Placebo N= 153 Relative Risk (95% CI) Del < 37 wks 111 (36.3%) 84 (54.9%) 0.66 ( )