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COMPLETED

A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

NCT02787213 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Study Locations (18)

California

  • University of California, Irvine Medical Center — Orange
  • UC San Diego Health — San Diego

Colorado

  • University of Colorado-Denver — Aurora
  • Denver Health Medical Center — Denver

Massachusetts

  • Boston Medical Center — Boston
  • Baystate Medical Center — Springfield

North Carolina

  • University of North Carolina — Chapel Hill
  • Duke University Medical Center — Durham

South Carolina

  • Medical University of South Carolina — Charleston
  • Greenville Health System — Greenville

Arizona

  • Maricopa Integrated Health Systems — Phoenix

Illinois

  • Northwestern Memorial Hospital — Chicago

Indiana

  • Indiana University Medical Center — Indianapolis

Trial Details

FieldValue
Enrollment Target 5,011 participants
Start Date 2016-08
Est. Completion 2019-06

Sponsor

Sera Prognostics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02787213

The ClinicalTrials.gov registry entry for NCT02787213 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,011 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sera Prognostics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Preterm Birth appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02787213 reports 18 study locations spanning 13 distinct geographic areas — top geographies include California, Colorado, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02787213 about?

NCT02787213 is a clinical study titled "A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor". 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...

What is the current status of trial NCT02787213?

This trial is currently completed. The enrollment target is 5,011 participants. The study started on 2016-08. Estimated completion is 2019-06.

What conditions does trial NCT02787213 study?

This clinical trial studies the following conditions: Preterm Birth. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT02787213?

This trial is sponsored by Sera Prognostics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02787213 being conducted?

This trial has 18 study locations across Arizona, California, Colorado, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial