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A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP)

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ClinicalTrials.gov Identifier: NCT02787213
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Sera Prognostics, Inc.

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.

Condition or disease
Preterm Birth

Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2023

Group/Cohort
Women with preterm delivery
Women without preterm delivery



Primary Outcome Measures :
  1. Area under the receiver operator characteristic curve (AUROC) for prediction of preterm versus term birth using freshly collected specimens. [ Time Frame: Up to 30 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women, 18 years or older, who are receiving prenatal care.
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787213


Contacts
Contact: Durlin E Hickok, MD 206-660-0301 dhickok@seraprognostics.com
Contact: Angela Fox, MS 206-465-0905 afox@seraprognostics.com

Locations
United States, Arizona
Maricopa Integrated Health Systems Recruiting
Phoenix, Arizona, United States, 85250
Contact: Dean Coonrod, MD    602-344-5119    dean_coonrod@dmgaz.org   
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Deborah Wing, MD    714-456-5967    dwing@uci.edu   
UC San Diego Health Recruiting
San Diego, California, United States, 92103
Contact: Louise Laurent, MD/PhD    858-246-1405    llaurent@ucsd.edu   
United States, Colorado
University of Colorado-Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily Su, MD    303-724-9227    emily.su@ucdenver.edu   
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Kent Heyborne, MD    303-602-9731    kent.heyborne@dhha.org   
United States, Connecticut
Yale-New Haven Hospital Withdrawn
New Haven, Connecticut, United States, 06520
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: William Grobman, MD    312-472-3970    w-grobman@northwestern.edu   
United States, Indiana
Indiana University Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: David Haas, MD    317-880-3960    dahaas@iu.edu   
United States, Louisiana
Ochsner Baptist Medical Center Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Sherry Longo, MD    504-842-4151    slongo@ochsner.org   
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Glenn Markenson, MD    617-414-2275    glenn.markenson@bmc.org   
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Corina Schoen, MD    413-794-9939      
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kim Boggess, MD    919-966-1601    kboggess@med.unc.edu   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Amy Murtha, MD    919-684-6327      
United States, Oklahoma
University of Oklahoma Health Science Center Withdrawn
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Leonardo M Pereira, MD    503-418-4500    pereiral@ohsu.edu   
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jason Baxter, MD    215-955-9238    jason.baxter@jefferson.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29485
Contact: Scott Sullivan, MD    843-792-4500    sullivas@musc.edu   
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Amy Crockett, MD    864-455-1600    acrockett@ghs.org   
United States, Tennessee
Regional Obstetrical Consultants Active, not recruiting
Chattanooga, Tennessee, United States, 37405
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: George Saade, MD    409-747-0476    gsaade@utmb.edu   
Sponsors and Collaborators
Sera Prognostics, Inc.
Investigators
Study Chair: Durlin E Hickok, MD Sera Prognostics

Publications:

Responsible Party: Sera Prognostics, Inc.
ClinicalTrials.gov Identifier: NCT02787213     History of Changes
Other Study ID Numbers: SP 014
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared once it is published.

Keywords provided by Sera Prognostics, Inc.:
proteomics
pregnancy
biomarkers
preterm birth

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