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
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...
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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...
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Fresno, California
Principal Investigator: Conrad Chao, MD
Phone: 559-499-6549
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Kansas City, Kansas 66160
Principal Investigator: Carl Weiner, MD
Phone: 913-588-6287
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