The Biomarker Study

Preterm birth (PTB) is a leading contributor to perinatal morbidity and mortality. While
patients with preterm labor (PTL) are at an increased risk for PTB, not all PTL patients
will deliver preterm. In patients with PTB, there is a high prevalence of 'intrauterine
inflammation' as demonstrated by a large body of evidence. The presence of inflammation is
noted by infiltration of inflammatory cells in the placenta and/or maternal fever in labor
and/or elevation of cytokines in the amniotic fluid.

Despite this significant association of inflammation with PTB, identification of women
destined to deliver preterm by inflammatory markers in maternal blood has not been
successful. To date, it has been difficult to determine which patients with PTL will
experience PTB. Identification of biomarkers, such as high sensitivity C-Reactive Protein
(hsCRP) as well as others such as sICAM, Pentraxin, sE-Selectin, and CxCL-10 in maternal
serum and in placental cord blood, may help to serve three very important clinical aims. 1)
Identification of novel biomarkers in maternal serum could help to distinguish those women
with PTL who are most likely to deliver PTB. 2) These biomarkers may have a high negative
predictive value and thus identify those women who are not likely to deliver preterm,
avoiding undue hospital admission and medical therapies. 3) Select biomarkers in the
mother and/or in cord blood may serve to identify those preterm neonates at greatest risk
for adverse outcome. Through improved identification of these infants, studies with
targeted therapies to reduce adverse neonatal outcomes in preterm neonates become feasible.

This study involves a cohort assessment of women at risk for Preterm birth secondary to
preterm labor, preterm premature rupture of membranes (PPROM), and cervical insufficiency
(CI), between 22-0/7 and 33-6/7 weeks gestational age. We will obtain information regarding
patients' pertinent past medical and obstetric history as well as small samples of maternal
blood at up to four occasions, small samples of placental cord blood, a maternal saliva
sample, and an infant buccal swab. We will follow each of these patient's pregnancy
outcomes, and determine if there are any correlations between levels of certain biomarkers
and latency to delivery as well as composite adverse neonatal outcomes. In women with PTB <
37 weeks, cord blood will be collected (as well as maternal saliva and an infant buccal
swab) and biomarkers compared between those infants with and without specific adverse
neonatal outcomes. Maternal saliva and buccal will be collected on all women and infants
enrolled.