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 |
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 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.
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
171 Ashley Avenue
Charleston, South Carolina 29425
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...
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
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...
Click here to add this to my saved trials
Fresno, California
Principal Investigator: Conrad Chao, MD
Phone: 559-499-6549
Click here to add this to my saved trials
Kansas City, Kansas 66160
Principal Investigator: Carl Weiner, MD
Phone: 913-588-6287
Click here to add this to my saved trials