The Biomarker Study
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.
Inclusion Criteria:

 -  Women with singleton pregnancies between 22-0/7 and 33-6/7 weeks gestational age who
 present to the Hospital of the University of Pennsylvania 'Perinatal Evaluation
 Center' (PEC) complaining of PTL, PPROM, or CI.

 -  Women who present to Labor and Delivery and will deliver (or have just delivered) a
 single infant preterm (22-0/7 to 36-6/7 weeks) at HUP.

 Exclusion Criteria:

 -  Multiple-gestation, major fetal anomaly, fetal demise, severe preeclampsia prior to
 enrollment, patients on chronic steroid use or immunosuppressive drugs, patients with
 significant (active) immunological disease (AIDS, SLE), acute febrile illness (such as
 with active influenza or pyelonephritis), and pregestational diabetes.