Rupture of Fetal Membranes Clinical Trial
Official title:
Clinical Evaluation of the AmniSure ROM Test
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. ;
Observational Model: Case-Only, Time Perspective: Prospective