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

April 12, 2021 updated by: Sera Prognostics, Inc.
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5011

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85250
        • Maricopa Integrated Health Systems
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
      • San Diego, California, United States, 92103
        • UC San Diego Health
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado-Denver
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Baptist Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29485
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System
    • Tennessee
      • Chattanooga, Tennessee, United States, 37405
        • Regional Obstetrical Consultants
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women, 18 years or older, who are receiving prenatal care.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women with preterm delivery
Women without preterm delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sera Prognostics, Inc.

Investigators

  • Study Chair: Durlin E Hickok, MD, Sera Prognostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (ESTIMATE)

June 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP 014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared once it is published.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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