Study participants were identified among pregnant women during their first prenatal visit and were recruited as part of the Newborn Epigenetics STudy (NEST).68 (link) Between 2009 and 2011, pregnant women were recruited from five prenatal clinics with delivery capabilities at Duke and Durham Regional hospitals, the only two obstetric facilities serving Durham and neighboring counties. Eligibility criteria were age 18 and older and intention to use these obstetric facilities for delivery. Exclusion criteria included plans to relinquish custody of the child, plans to move from the area in the subsequent three years, and infection with HIV due to the limited research on the relationships between HIV, its treatment, and DNA methylation in the offspring.
As of December 2011, 2,548 women had been approached and 1,700 (66.6%) consented to participate. The 848 women who declined were similar to those who consented with respect to age (p = 0.70) but different with respect to race/ethnicity (p < 0.001), with the group that declined more likely to be Asian and Native American but similar with respect to other racial/ethnic groups. Of the 1,700 women, 396 were withdrawn due to miscarriage (n = 109), death of infant after birth (n = 4), illiteracy (n = 1), being underage (n = 1), or other (n = 21); or refused further participation (n = 146); or gave birth at an outside hospital (n = 114), such that 1304 (76.7%) women remained enrolled in the study up to the time of analysis. These analyses are limited to the 922 women in whom both depressed mood and parturition data are available. The study protocol was approved by the Duke University Institutional Review Board (IRB).
As of December 2011, 2,548 women had been approached and 1,700 (66.6%) consented to participate. The 848 women who declined were similar to those who consented with respect to age (p = 0.70) but different with respect to race/ethnicity (p < 0.001), with the group that declined more likely to be Asian and Native American but similar with respect to other racial/ethnic groups. Of the 1,700 women, 396 were withdrawn due to miscarriage (n = 109), death of infant after birth (n = 4), illiteracy (n = 1), being underage (n = 1), or other (n = 21); or refused further participation (n = 146); or gave birth at an outside hospital (n = 114), such that 1304 (76.7%) women remained enrolled in the study up to the time of analysis. These analyses are limited to the 922 women in whom both depressed mood and parturition data are available. The study protocol was approved by the Duke University Institutional Review Board (IRB).
