Screening To Obviate Preterm Birth

NCT01868308 | Completed

• 1 other identifier: 817085
• Study Type: observational
• Target: 589
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Preterm birth

  The primary outcome is preterm birth defined as delivery before 37 weeks.

  Enrollment through delivery

Secondary Outcomes (1)

• Early preterm birth

  Enrollment through delivery

Study Arms (1)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Women with a multi-fetal pregnancy
• Intra uterine fetal demise
• Preterm premature rupture of membranes
• Overt chorioamnionitis

Sponsors & Collaborators

• University of Pennsylvania: lead
• Hologic, Inc.: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A vaginal swab will be collected during the patients clinical admission exam by a nurse.

MeSH Terms

Conditions

Obstetric Labor, Premature; Colic; Back Pain; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes

Study Officials

• Michal A Elovitz, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 4, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)