Study Population and Design
This was a single center, prospective, observational cohort study
(NCT02639676). Potential study participants were recruited from 3 local
hospitals in Indianapolis, IN USA. Inclusion criteria for the study
cohort included a clinical diagnosis of Pre-E (using definitions
contained in the American College of Obstetrcis and Gynecology Task
Force on Hypertension in Pregnancy 2013 report) with anticipated
delivery between 26-40 weeks GA determined by best obstetrical dating
(last menstrual period confirmed by ultrasound) [14]. We also
recruited a comparison cohort of infants born from normotensive pregnant
women with anticipated delivery between 26-40 weeks GA determined by
best obstetrical dating. Exclusion criteria included multiple gestation
pregnancy, prenatally identified fetal cardiopulmonary defects, known
fetal chromosomal disorders, women with diabetes mellitus, and women
with chronic or gestational hypertension. Prematurity was not an
exclusion criterion for either cohort, and the final cohorts were
comprised of term and preterm infants. Prior to initiation of this
study, we received approval from the Indiana University Institutional
Review Board. The mothers of infant study participants all provided
written informed consent.
We used the electronic medical record to obtain maternal clinical
information, such as maternal medications (e.g. antenatal steroids,
magnesium sulfate, other anti-hypertensive therapies), tobacco use, and
family history of asthma. We also obtained neonatal clinical information
such as birth weight and length, gestational age at birth, sex, race,
and need for interventions such as exogenous surfactant therapy,
positive pressure ventilation, and supplement oxygen use.
Following discharge from the hospital, we performed monthly telephone
surveys to track episodes of wheezing, respiratory medication use (e.g.
inhaled bronchodilators and inhaled corticosteroids), and
hospitalizations for respiratory related illness.