Genetic Variations in Three Interacting Single Nucleotide Polymorphisms 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
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.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
To determine if carriage of one of the high risk genetic patterns, as identified by Menon et al. (2006), is present in 65% of Black mothers and their infants with preterm births and 35% of Black mothers and their infants with term births.
Gail McCain, PhD
University of Miami
United States: Institutional Review Board
|Broward General Medical Center||Fort Lauderdale, Florida 33316|