Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families

Research Design and Methods Study Design A gene association study, using a case-control design, will be utilized. Each case and each control will include the genetic mother and her newborn infant. Setting A multicenter (n=2) study is proposed. St. Mary's Medical Center in West Palm Beach, Florida and Broward General Medical Center in Ft. Lauderdale, Florida are the two research centers. Sample: It is estimated that a sample of 166 mother-infant dyads (332 individuals) will be needed to test the study hypotheses. The sample size has been adjusted to allow for a 10% drop out rate. The control group will include 110 term mothers and 110 term infants. The case group will include 56 preterm mothers and 56 preterm infants. It is expected that each site will be able to enroll 83 family dyads in less than two years. A reasonable effort will be made to enroll eligible family dyads. Enrollment of less than 50% of eligible subjects will lead to a site review to remedy the problem or result in possible site closure. Enrollment for each site will be a minimal of 66 family dyads and a maximum of 100 family dyads.