CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,011 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02787213
NCT02787213N/ACompleted

A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

Sera Prognostics, Inc.·observational·Posted Jun 1, 2016·Updated Apr 14, 2021

In Brief

An observational study for Preterm Birth. Completed, enrolled 5,011 participants across 18 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 1, 2016
Enrollment StartAug 1, 2016
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.1 years ago