Biomarkers Associated With Spontaneous Preterm Birth Less Than 32 Wks Gestation

Completed

Conditions studied: Preterm Labor, Preterm Birth

In brief

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.

Key facts

Study ID

NCT02317315

Run by

Ranjith Kamity, MD

People needed

24

Starts

2013-01-01

Expected to finish

2017-09-07

Last updated by the study team

2018-01-29

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Winthrop University Hosptial — Mineola, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.