Clinical trial NCT01868308: Screening To Obviate Preterm Birth
Official title: Screening To Obviate Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Labor
Preterm Contractions
Abdominal Cramping
Back Pain
Vaginal Pressure
Vaginal Bleeding
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2013-06-04
Enrollment: 589
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women presenting to the perinatal evaluation center at the Hospital of the University of Pennsylvania with preterm labor symptoms will be approached for the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Preterm birth
timeFrame: Enrollment through delivery
Secondary outcomes:
measure: Early preterm birth
timeFrame: Enrollment through delivery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michal A Elovitz, MD
role: PRINCIPAL_INVESTIGATOR
References: