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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787213
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : February 27, 2019
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

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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 : September 2019
Estimated Study Completion Date : September 2024

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 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.

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


Locations
Show Show 18 study locations
Sponsors and Collaborators
Sera Prognostics, Inc.
Investigators
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Study Chair: Durlin E Hickok, MD Sera Prognostics
Publications:

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Responsible Party: Sera Prognostics, Inc.
ClinicalTrials.gov Identifier: NCT02787213    
Other Study ID Numbers: SP 014
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
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:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications