Clinical Evaluation of the AmniSure ROM Test



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 50
Updated:4/21/2016
Start Date:August 2013
End Date:June 2016
Contact:Andrew E Schumacher
Email:andrew.schumacher@qiagen.com
Phone:301-944-7094

Use our guide to learn which trials are right for you!

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Subjects who have placenta previa.

- Subjects who have heavy vaginal bleeding.

- Subjects who have had digital vaginal examination immediately prior to evaluation for
ROM.
We found this trial at
4
sites
Kansas City, Kansas 66160
Principal Investigator: Carl Weiner, MD
Phone: 913-588-6287
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 901-230-4284
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Scott Sullivan, MD
Phone: 843-792-6992
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Fresno, California
Principal Investigator: Conrad Chao, MD
Phone: 559-499-6549
?
mi
from
Fresno, CA
Click here to add this to my saved trials