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Efficacy Study of Rapid Immunoassay Diagnostic Test Utilizing PP12 and AFP, ROM Plus

NCT02524691 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 324

Last updated 2016-08-09

No results posted yet for this study

Summary

The study is designed to establish the level of agreement between the ROM Plus test and the diagnosis of ROM as defined by the patient's clinical course, with respect to a population of pregnant women who present to the clinical site with signs and symptoms suggestive of ROM.

Conditions

  • PROM

Interventions

DEVICE

Use of Rapid Immunoassay Tests for the Detection of PROM

Patient will undergo both rapid immunoassay tests for the detection of PROM and the standard of care for the diagnosis of PROM using a sterile speculum (SSE). Women who cannot be confirmed clinically by the SSE will undergo an ultrasound evaluation to determine the amniotic fluid index. The patient will be treated according to the results of the SSE and ultrasound, not the results of rapid immunoassay tests. The provider conducting the SSE will be blinded to the results of the rapid immunoassay tests.

Sponsors & Collaborators

  • Clinical Innovations, LLC

    lead INDUSTRY

Principal Investigators

  • Ross W McQuivey, MD · Clinical Innovations, LLC

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-05-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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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 NCT02524691 on ClinicalTrials.gov