Screening To Obviate Preterm Birth



Status:Completed
Conditions:Back Pain, Women's Studies, Metabolic
Therapuetic Areas:Musculoskeletal, Pharmacology / Toxicology, Reproductive
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:January 2013
End Date:June 2015

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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.

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.

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.

Exclusion Criteria:

- Women with a multi-fetal pregnancy

- Intra uterine fetal demise

- Preterm premature rupture of membranes

- Overt chorioamnionitis
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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mi
from
Philadelphia, PA
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