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.
The main goal of this study is to show that when performed by less qualified personnel, the AmniSure® ROM Test is so simple and accurate that the likelihood of erroneous results by the Intended-User is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.
Study Type
OBSERVATIONAL
Enrollment
383
Comparison of AmniSure ROM test to clinical diagnosis of ROM.
University of California San Francisco- Fresno
Fresno, California, United States
Indiana University
Indianapolis, Indiana, United States
Kansas University Medical Center Research Institute, Inc
Kansas City, Kansas, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes.
The investigational AmniSure ROM test will be compared to the three standard tests of nitrazine, ferning and pooling to determine rupture of fetal membranes.
Time frame: One time at time of enrollment
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