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Clinical Evaluation of the AmniSure ROM Test

NCT01847820 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 383

Last updated 2016-07-14

No results posted yet for this study

Summary

To show that having less qualified personnel (non-Laboratory trained professionals) perform the test yields the same result as if a Laboratory trained professional performed the test.

Conditions

  • Rupture of Fetal Membranes

Interventions

DEVICE

AmniSure ROM test

Comparison of AmniSure ROM test to clinical diagnosis of ROM.

Sponsors & Collaborators

  • QIAGEN Gaithersburg, Inc

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

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 NCT01847820 on ClinicalTrials.gov