Clinical trial NCT02787213: A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor
Official title: A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: proteomics
pregnancy
biomarkers
preterm birth
Lead sponsor: Sera Prognostics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-01
Enrollment: 5011
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women, 18 years or older, who are receiving prenatal care.

Brief summary: Prospective multicenter observational study to further develop and validate a preterm birth risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks gestation. A single maternal peripheral blood sample will be collected for analysis. Data related to potential risk factors for preterm birth will be obtained through maternal interview and review of medical records. Subjects will be followed through the delivery process to assess the course of pregnancy, labor, and to document any related maternal complications. Neonatal outcomes will be gathered from the medical record for up to 28 days of life or discharge, whichever occurs first.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older
* Subject has singleton gestation
* Subject is able to provide consent
* Gestational age is confirmed by a documented crown rump length on an ultrasound performed at the study site within 6 0/7 weeks and 13 6/7 weeks gestation (first trimester)
* Subject has no signs and/or symptoms of preterm labor and has intact membranes
* Investigator believes subject is willing to comply with study visits and procedures
* Investigator believes the subject's delivery data will be available within 15 business days from delivery, and neonatal data will be available for data collection purposes within 15 business days from discharge

Exclusion Criteria:

* The subject has a planned cesarean section or induction of labor prior to 370/7 weeks of gestation
* The subject has a planned cerclage placement for the current pregnancy
* There is a known or suspected fetal anomaly or chromosomal abnormality
* The subject has had a blood transfusion during the current pregnancy
* The subject has known elevated bilirubin levels (hyperbilirubinemia)
* The subject has taken or plans to take any of the following medications during the current pregnancy:

  * Progesterone or progesterone-derivative medication after 13 6/7 weeks gestation
  * Enoxaparin, heparin, heparin sodium, low molecular weight heparin after first day of last menstrual period
* The subject has participated in, or plans to participate in, an interventional treatment study during the current pregnancy
* The current pregnancy was previously a multiple gestation that is now a single fetus due to reduction, vanishing twin, etc.

Primary outcomes:
measure: Area under the receiver operator characteristic curve (AUROC) for prediction of preterm versus term birth using freshly collected specimens.
timeFrame: Up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health Systems
state: Arizona
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: San Diego
country: United States
facility: UC San Diego Health
state: California
city: Aurora
country: United States
facility: University of Colorado-Denver
state: Colorado
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Chattanooga
country: United States
facility: Regional Obstetrical Consultants
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Sera Prognostics
name: Durlin E Hickok, MD
role: STUDY_CHAIR
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