Screening To Obviate Preterm Birth (STOP)

University of Pennsylvania

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01868308

817085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 589 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

589 participants in 1 patient group

Preterm Labor

Description:

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.