Clinical Research Studies

Preterm delivery is a leading cause of neonatal mortality and continues to be a major public health concern. Although some pregnant women will present with preterm labor (uterine contractions), most will not progress to actual preterm delivery (birth). Identifying which pregnant women presenting with preterm labor that will actually progress to preterm delivery is a challenge for clinicians. Studies have demonstrated that measuring biomarkers (inflammatory mediators, microRNA and cytokines) in intra-uterine tissues (placenta, amniotic membranes and amniotic fluids) can predict preterm labor progression to delivery. However obtaining such samples are invasive and can be dangerous. The overall goal of this study is to identify biomarkers from samples from non-invasive sites that will increase the clinician’s ability to identify patients who present with second trimester preterm labor (uterine contractions) that will progress to preterm delivery. Specifically, we will measure biomarkers from non-invasive samples (blood, urine, vaginal secretions and saliva) in pregnant women (at less than 34 weeks gestation) presenting to NYU Winthrop Hospital with preterm labor (contractions). We will compare two groups; 1) pregnant women with preterm labor that deliver within 3 days after admission to the hospital vs. 2) women with preterm labor that deliver more than 3 days after admission. We will need 60 samples from group 1. Since approximately 25% of pregnant women presenting with preterm labor will actually end with preterm delivery, we will enroll a total of 240 subjects. After consent is obtained, samples (blood, urine, vaginal secretions and saliva) will be collected at the time of the hospital admission. If the patient did not progress to preterm delivery and was discharged home, no more samples will be obtained. If the patient continued to be admitted in the hospital for observation, weekly samples will be obtained whenever possible. When subjects progress to active labor and delivery, samples will be collected (blood, urine, vaginal secretions and saliva) as well as placenta/fetal membranes after delivery. The collected samples will be transported, processed and stored at the PI lab at NYU Winthrop Hospital. Biomarkers (such as inflammatory mediators, cytokines and microRNA) will be evaluated to predict preterm delivery in these pregnant women. A secondary objective is to correlate the inflammatory biomarkers obtained during pregnancy with the neonatal outcome (obtained by review of the neonatal medical records).