Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
QIAGEN Gaithersburg, Inc
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.
Age
18–50
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Subjects must be pregnant.
Subjects must be between 18 and 50 years of age and have a gestational age of 11.0-42.0 weeks.
Subjects reporting suspicion, signs, or symptoms suggestive of ROM, PROM, PPROM.
Subjects providing informed consent.
You may not be if
Subjects who have placenta previa.
Subjects who have heavy vaginal bleeding.
Subjects who have had digital vaginal examination immediately prior to evaluation for ROM.
Clareo Health | Clinical Evaluation of the AmniSure ROM Test
