Screening To Obviate Preterm Birth (STOP)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Screening To Obviate Preterm Birth|
- Preterm birth [ Time Frame: Enrollment through delivery ] [ Designated as safety issue: Yes ]The primary outcome is preterm birth defined as delivery before 37 weeks.
- Early preterm birth [ Time Frame: Enrollment through delivery ] [ Designated as safety issue: Yes ]The secondary outcome is "early" preterm birth defined as delivery before 34 weeks.
Biospecimen Retention: Samples With DNA
A vaginal swab will be collected during the patients clinical admission exam by a nurse.
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Symptomatic women with singleton pregnancy at high risk for preterm birth between 22 - 33 6/7 weeks gestational age. We define "high risk for preterm birth" as women who present to our triage unit with complaints of preterm labor, including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, and vaginal bleeding.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868308
|Contact: Meghan E Ryan||215-615-6047||OBResearch@uphs.upenn.edu|
|Contact: Brittany A Araujo, BS||215-615-6048||OBResearch@uphs.upenn.edu|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Meghan E Ryan 215-615-6047 OBResearch@uphs.upenn.edu|
|Principal Investigator: Michal A Elovitz, MD|
|Sub-Investigator: Jamie A Bastek, MD, MSCE|
|Principal Investigator:||Michal A Elovitz, MD||University of Pennsylvania|