Screening To Obviate Preterm Birth

Completed

• Conditions: Preterm Labor; Vaginal Pressure; Preterm Contractions; Abdominal Cramping; Back Pain; Vaginal Bleeding

• Registration Number: NCT01868308
• Lead Sponsor: University of Pennsylvania

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-04
• Primary Completion: 2015-02
• Study Completion: 2015-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 589

Inclusion Criteria

• Singleton pregnancy between 22- 33 6/7 weeks of gestational age.
• Must be experiencing one ore more of the following symptoms including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, or light vaginal bleeding.

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Exclusion Criteria

• Women with a multi-fetal pregnancy
• Intra uterine fetal demise
• Preterm premature rupture of membranes
• Overt chorioamnionitis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preterm birth	Enrollment through delivery	The primary outcome is preterm birth defined as delivery before 37 weeks.

Secondary Outcome Measures

Name	Time	Method
Early preterm birth	Enrollment through delivery	The secondary outcome is "early" preterm birth defined as delivery before 34 weeks.

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States