A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

Description

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.

Study Start Date

August, 01 2016

Estimated Completion Date

March 2023

Interventions

No interventions cited

Study ID

Sera Prognostics, Inc. -- SP 014

Status

Recruiting

Trial ID

NCT02787213

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

4000

Sponsor

Sera Prognostics, Inc.

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.

Gender

Female

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (48)

Study Location Distance Name Phone Email
YaleNew Haven Hospital - New Haven, Connecticut 18.1 miles None None None
YaleNew Haven Hospital - New Haven, Connecticut 18.1 miles None None None
YaleNew Haven Hospital - New Haven, Connecticut 18.1 miles None None None
Baystate Medical Center - Springfield, Massachusetts 70.9 miles Corina Schoen MD 413-794-9939 None
Baystate Medical Center - Springfield, Massachusetts 70.9 miles Corina Schoen MD 413-794-9939 None
Baystate Medical Center - Springfield, Massachusetts 70.9 miles Corina Schoen MD 413-794-9939 None
Thomas Jefferson University Hospital - Philadelphia, Pennsylvania 133.3 miles Jason Baxter MD 215-955-9238 jason.baxter@jefferson.edu
Thomas Jefferson University Hospital - Philadelphia, Pennsylvania 133.3 miles Jason Baxter MD 215-955-9238 jason.baxter@jefferson.edu
Thomas Jefferson University Hospital - Philadelphia, Pennsylvania 133.3 miles Jason Baxter MD 215-955-9238 jason.baxter@jefferson.edu
Boston Medical Center - Boston, Massachusetts 137.1 miles Glenn Markenson MD 617-414-2275 glenn.markenson@bmc.org
Boston Medical Center - Boston, Massachusetts 137.1 miles Glenn Markenson MD 617-414-2275 glenn.markenson@bmc.org
Boston Medical Center - Boston, Massachusetts 137.1 miles Glenn Markenson MD 617-414-2275 glenn.markenson@bmc.org
Duke University Medical Center - Durham, North Carolina 474.1 miles Amy Murtha MD 919-684-6327 None
Duke University Medical Center - Durham, North Carolina 474.1 miles Amy Murtha MD 919-684-6327 None
Duke University Medical Center - Durham, North Carolina 474.1 miles Amy Murtha MD 919-684-6327 None
Indiana University Medical Center - Indianapolis, Indiana 686.4 miles David Haas MD 317-880-3960 dahaas@iu.edu
Indiana University Medical Center - Indianapolis, Indiana 686.4 miles David Haas MD 317-880-3960 dahaas@iu.edu
Indiana University Medical Center - Indianapolis, Indiana 686.4 miles David Haas MD 317-880-3960 dahaas@iu.edu
Medical University of South Carolina - Charleston, South Carolina 686.9 miles Scott Sullivan MD 843-792-4500 sullivas@musc.edu
Medical University of South Carolina - Charleston, South Carolina 686.9 miles Scott Sullivan MD 843-792-4500 sullivas@musc.edu
Medical University of South Carolina - Charleston, South Carolina 686.9 miles Scott Sullivan MD 843-792-4500 sullivas@musc.edu
Northwestern Memorial Hospital - Chicago, Illinois 745.5 miles William Grobman MD 312-472-3970 w-grobman@northwestern.edu
Northwestern Memorial Hospital - Chicago, Illinois 745.5 miles William Grobman MD 312-472-3970 w-grobman@northwestern.edu
Northwestern Memorial Hospital - Chicago, Illinois 745.5 miles William Grobman MD 312-472-3970 w-grobman@northwestern.edu
Regional Obstetrical Consultants - Chattanooga, Tennessee 781.6 miles None None None
Regional Obstetrical Consultants - Chattanooga, Tennessee 781.6 miles None None None
Regional Obstetrical Consultants - Chattanooga, Tennessee 781.6 miles None None None
Ochsner Baptist Medical Center - New Orleans, Louisiana 1,226.2 miles Sherry Longo MD 504-842-4151 slongo@ochsner.org
Ochsner Baptist Medical Center - New Orleans, Louisiana 1,226.2 miles Sherry Longo MD 504-842-4151 slongo@ochsner.org
Ochsner Baptist Medical Center - New Orleans, Louisiana 1,226.2 miles Sherry Longo MD 504-842-4151 slongo@ochsner.org
University of Oklahoma Health Science Center - Oklahoma City, Oklahoma 1,371.2 miles None None None
University of Oklahoma Health Science Center - Oklahoma City, Oklahoma 1,371.2 miles None None None
University of Oklahoma Health Science Center - Oklahoma City, Oklahoma 1,371.2 miles None None None
University of Texas Medical Branch - Galveston, Texas 1,464.4 miles George Saade MD 409-747-0476 gsaade@utmb.edu
University of Texas Medical Branch - Galveston, Texas 1,464.4 miles George Saade MD 409-747-0476 gsaade@utmb.edu
University of Texas Medical Branch - Galveston, Texas 1,464.4 miles George Saade MD 409-747-0476 gsaade@utmb.edu
Denver Health Medical Center - Denver, Colorado 1,668.0 miles Kent Heyborne MD 303-602-9731 kent.heyborne@dhha.org
Denver Health Medical Center - Denver, Colorado 1,668.0 miles Kent Heyborne MD 303-602-9731 kent.heyborne@dhha.org
Denver Health Medical Center - Denver, Colorado 1,668.0 miles Kent Heyborne MD 303-602-9731 kent.heyborne@dhha.org
Maricopa Integrated Health Systems - Phoenix, Arizona 2,175.0 miles Dean Coonrod MD 602-344-5119 dean_coonrod@dmgaz.org
Maricopa Integrated Health Systems - Phoenix, Arizona 2,175.0 miles Dean Coonrod MD 602-344-5119 dean_coonrod@dmgaz.org
Maricopa Integrated Health Systems - Phoenix, Arizona 2,175.0 miles Dean Coonrod MD 602-344-5119 dean_coonrod@dmgaz.org
UC San Diego Health - San Diego, California 2,472.6 miles Louise Laurent MDPhD 858-246-1405 llaurent@ucsd.edu
UC San Diego Health - San Diego, California 2,472.6 miles Louise Laurent MDPhD 858-246-1405 llaurent@ucsd.edu
UC San Diego Health - San Diego, California 2,472.6 miles Louise Laurent MDPhD 858-246-1405 llaurent@ucsd.edu
University of California Irvine Medical Center - Orange, California 2,477.9 miles Deborah Wing MD 714-456-5967 dwing@uci.edu
University of California Irvine Medical Center - Orange, California 2,477.9 miles Deborah Wing MD 714-456-5967 dwing@uci.edu
University of California Irvine Medical Center - Orange, California 2,477.9 miles Deborah Wing MD 714-456-5967 dwing@uci.edu

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