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A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

NCT02787213 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5011

Last updated 2021-04-14

No results posted yet for this 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

Sponsors & Collaborators

  • Sera Prognostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Durlin E Hickok, MD · Sera Prognostics

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787213 on ClinicalTrials.gov