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 |
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.
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.
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
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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