2.2. Participants
RECRUITMENT
Participants were 18 years of age or older with a singleton pregnancy who could read and speak in English or Spanish, and only women who did not meet these criteria were excluded. The trial was conducted under as an Investigational New Drug trial (#129,482), and the FDA limited the exclusion criteria to ensure recruitment was generalizable. In brief, the group was diverse in race and ethnicity (67.5% white, 26% Black/African American, 20.7% Hispanic/Latina, 3.1% Asian, 2.7% Bi- or Multiracial, and 0.5% American Indian or Alaskan Native), education level (ranging from less than high school (14.5%) to a doctorate (8%)), and by family income (<USD 15,000, 21% to >USD 150,000, 11%). Seventy percent had a prior pregnancy (