Non Invasive Biomarkers to Identify Subjects at Risk for Preterm Delivery
Non Invasive Biomarkers to Identify Subjects at Risk for Preterm Delivery
The goal of this study is to identify a non-invasive predictor or predictors that will
 increase the clinician's ability to identify patients with preterm labor (PTL) at risk for
 preterm delivery (PTD). Through these studies we also hope to reveal potential therapeutic
 targets in the prevention of prevention of preterm births.

 The study hypothesis is that we can identify non-invasive predictors of PTL at risk for PTD.
STUDY DESIGN This is a prospective study involving a cohort of pregnant subjects with
 pre-term labor. Maternal blood and cervical/vaginal fluid will be collected from consenting
 subjects with preterm labor. Repeat sampling of cervical fluid will occur as often as weekly
 until the time of delivery. Relevant clinical and demographic data will be recorded. Levels
 of prostaglandins (PG's), lipocalin-type prostaglandin D2 synthase (L-PGDS) and cytokines
 will be determined using ELISA. DNA will also be extracted from maternal blood for SNP
 analysis of cytokine genes. At the time of delivery, cord blood and placenta samples will be
 collected if logistically possible (during regular laboratory hours). To determine fetal
 levels of PG's, L-PGDS and cytokines in cord blood will be analyzed using ELISA. Placental
 samples will be used for in vitro studies aimed at investigating the placental regulatory
 pathways of cytokine and PG production. Placental samples will also be processed and embedded
 in paraffin for use in immunohistochemical studies in order to localize the expression of
 PG's and cytokines. Clinical delivery data will also be recorded.

 Gender of Subjects. Only female subjects will be included.

 Age of Subjects. The age of subjects will be restricted to 18-45 years.

 Inclusion Criteria. Women with a diagnosis of preterm labor will be included in this study.
 Preterm labor will be diagnosed as

 Six or more contractions per hour associated with one of the following:

 1. cervical dilation >= 2 cm

 2. cervical effacement > 80%

 3. documented changes in dilation or effacement

 OR Cervical length less than 2.5 cm by ultrasound with or without contractions.

 Exclusion Criteria. Multiple pregnancy, fetal anomalies, abruptio placenta, preeclampsia,
 cervical dilation greater than 4 cm, clinical signs of infection and vaginal bleeding.

 Subject Capacity. All subjects included in this study will have the capacity to give informed
 consent.
Inclusion Criteria:

 -  Women with a diagnosis of preterm labor.

 Exclusion Criteria:

 -  Multiple pregnancy, fetal anomalies, abruptio placenta, preeclampsia, cervical
 dilation greater than 4 cm, clinical signs of infection and vaginal bleeding