Screening To Obviate Preterm Birth

Back Pain Clinical Trial

— STOP  

Official title:

Screening To Obviate Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868308
• Other study ID #: 817085
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: March 28, 2017
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Cramping
• Back Pain
• Obstetric Labor, Premature
• Premature Birth
• Preterm Contractions
• Preterm Labor
• Uterine Hemorrhage
• Vaginal Bleeding
• Vaginal Pressure

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth	The primary outcome is preterm birth defined as delivery before 37 weeks.	Enrollment through delivery
Secondary	Early preterm birth	The secondary outcome is "early" preterm birth defined as delivery before 34 weeks.	Enrollment through delivery