NCT01868308

Screening To Obviate Preterm Birth

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 589 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Our objective is to investigate the predictive value of a panel of biomarkers associated with two biologically plausible pathways of preterm birth: membrane breakdown and cervical remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin, and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm birth in an effort to better risk stratify this cohort.

Detailed description

Preterm Birth is a complex syndrome for which several different biologically plausible pathways have been proposed, including mechanical uterine distension, abruption, inflammation, and/or activation of the fetal hypothalamic-pituitary-axis. However, despite our knowing the complexity of this syndrome and the different pathways involved, there is a paucity of clinical studies investigating whether detection of more than one of these pathways in a single patient might enhance the identification of those at greatest risk for preterm birth. We propose investigating the predictive value of a panel of biomarkers associated with two biological plausible pathways - membrane breakdown and cervical remodeling - that must be involved in the pathogenesis of preterm birth. Specifically, we propose measuring cervical length and collecting cervicovaginal fetal fibronectin as well as a panel of novel cervicovaginal biomarkers that reflect molecular pathways involved in cervical remodeling in a prospectively collected cohort of symptomatic women with singleton fetuses at high risk for preterm birth. Through this study we hope improve risk stratification of this high risk cohort.

Conditions

• Preterm Labor
• Preterm Contractions
• Abdominal Cramping
• Back Pain
• Vaginal Pressure
• Vaginal Bleeding

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-02-01
• Completion: 2015-06-01
• First posted: 2013-06-04
• Last updated: 2017-03-30

Locations

1 site across 1 country: United States