Biomarkers Associated With Spontaneous Preterm Birth Less Than 32 Wks Gestation
Biomarkers Associated With Spontaneous Preterm Birth Less Than 32 Wks Gestation
Preterm delivery (PTD) is a leading cause of neonatal mortality and continues to be a major
 public health concern, reaching 12.9% in 2006, despite intense research to reverse this
 trend. Currently, fetal fibronectin (fFN) screening and cervical length determined by
 ultrasound are two tests which are proven to have benefit in the identification of those at
 greatest risk for preterm delivery. However the benefit of these tests is limited to
 situations where a negative result can avoid unnecessary interventions. Currently, maternal
 fetal monitoring is limited, as it is difficult to "see" what is going on in the placenta
 (maternal-fetal interface) without invasive measures such as placental biopsy or
 amniocentesis. Our goal for this study is to identify a group of biomarkers in non-invasive
 compartments (such as saliva, blood, urine, and/or cervical and vaginal secretions) that are
 associated with preterm labor and birth. We hypothesize that preterm labor will display an
 inflammatory profile, which consists of unique inflammatory biomarkers from different
 non-invasive bodily fluid compartments (such as Il-10 in urine, VEGF in cervical secretions,
 and IP-10 in saliva), that correlates with a high incidence of preterm birth.
Preterm delivery (PTD) is a leading cause of neonatal mortality and continues to be a major
 public health concern, reaching 12.9% in 2006, despite intense research to reverse this
 trend. Currently, fetal fibronectin (fFN) screening and cervical length determined by
 ultrasound are two tests which are proven to have benefit in the identification of those at
 greatest risk for preterm delivery. However the benefit of these tests is limited to
 situations where a negative result can avoid unnecessary interventions. The first goal of
 this study is to identify non-invasive predictor(s) that will increase the clinician's
 ability to identify patients who present with second trimester preterm labor (PTL) at risk
 for preterm delivery (PTD) ≤ 32 weeks gestation.

 Currently, maternal fetal monitoring is limited, as it is difficult to "see" what is going on
 in the placenta (maternal-fetal interface) without invasive measures such as placental biopsy
 or amniocentesis. Our preliminary study from term pregnancies has shown that a specific
 correlation of an intrauterine cytokine may be reflected in one noninvasive site but not
 another, depending upon the type of cytokine and the compartment from which it is secreted.
 Therefore, our second goal for this study is to identify inflammatory markers in non-invasive
 maternal compartments (such as saliva, blood, urine, and/or cervical and vaginal secretions)
 that have a strong association with placenta/fetal membranes at the time of preterm birth ≤
 32 weeks gestation.

 Pregnant women, under 32 weeks gestation, who are admitted to Winthrop University Hospital
 for evaluation of preterm labor will be eligible for this study. Women with indicated preterm
 births (i.e. pre-eclampsia), multiple pregnancies, known major fetal abnormality (ex. those
 that are known to be incompatible with life) and premature rupture of membranes will be
 excluded from this study. After consent is obtained, samples (blood, urine, saliva, vaginal,
 and cervical secretions) will be obtained and biomarkers will be identified using a Bio-Plex
 cytokine concentration assay. These women will than be followed until they deliver. Women who
 deliver after 32 weeks gestation will form our control group and women who deliver before 32
 weeks gestation will form our preterm birth group. Concentration of the biomarkers in the
 various maternal-fetal compartments will be analyzed and compared between the two groups. For
 all women who delivery ≤ 32 weeks gestation, non-invasive samples will also be collected
 around delivery and these cytokine levels will be compared to placenta/fetal membranes to
 access how well non-invasive fluids reflect the intrauterine environment.

 We hypothesize that preterm labor will display an inflammatory profile, which consists of
 unique inflammatory biomarkers from different non-invasive bodily fluid compartments (such as
 Il-10 in urine, VEGF in cervical secretions, and IP-10 in saliva), that correlates with a
 high incidence of preterm birth.
Inclusion Criteria:

 -  Pregnant women age 18-40 years old between 20 to 32 weeks gestation with singleton
 pregnancies and are admitted to Winthrop University Hospital for evaluation of preterm
 labor. Preterm labor will be defined as contractions every 5 minutes associated with
 cervical changes or cervical dilatation > 2cm with 80% effacement. Subjects must have
 reliable dates confirmed by early ultrasound.

 Exclusion Criteria:

 -  Indicated preterm births (i.e. pre-eclampsia), multiple pregnancies, known major fetal
 abnormality (ex. those that are known to be incompatible with life) and premature
 rupture of membranes.