Screening To Obviate Preterm Birth (STOP)

This study has been completed.
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01868308
First received: May 29, 2013
Last updated: December 22, 2015
Last verified: December 2015
  Purpose
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.

Condition
Preterm Labor
Preterm Contractions,
Abdominal Cramping
Back Pain
Vaginal Pressure
Vaginal Bleeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening To Obviate Preterm Birth

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Preterm birth [ Time Frame: Enrollment through delivery ] [ Designated as safety issue: Yes ]
    The primary outcome is preterm birth defined as delivery before 37 weeks.


Secondary Outcome Measures:
  • Early preterm birth [ Time Frame: Enrollment through delivery ] [ Designated as safety issue: Yes ]
    The secondary outcome is "early" preterm birth defined as delivery before 34 weeks.


Biospecimen Retention:   Samples With DNA
A vaginal swab will be collected during the patients clinical admission exam by a nurse.

Enrollment: 589
Study Start Date: January 2013
Study Completion Date: June 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preterm Labor
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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868308

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Hologic, Inc.
Investigators
Principal Investigator: Michal A Elovitz, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01868308     History of Changes
Other Study ID Numbers: 817085 
Study First Received: May 29, 2013
Last Updated: December 22, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on February 10, 2016