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Biomarkers Associated With Spontaneous Preterm Birth Less Than 32 Wks Gestation

NCT02317315 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2018-01-29

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Ranjith Kamity, MD

    lead OTHER

Principal Investigators

  • RANJITH KAMITY, MD · Winthrop University Hospital

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-01-02
Completion
2017-09-07

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02317315 on ClinicalTrials.gov