Status:
TERMINATED
Clinical Evaluation of the AmniSure ROM Test
Lead Sponsor:
QIAGEN Gaithersburg, Inc
Conditions:
Rupture of Fetal Membranes
Eligibility:
FEMALE
18-50 years
Brief Summary
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.
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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
- Subjects who have placenta previa.
- Subjects who have heavy vaginal bleeding.
- Subjects who have had digital vaginal examination immediately prior to evaluation for ROM.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT01847820
Start Date
August 1 2013
End Date
July 1 2016
Last Update
July 14 2016
Active Locations (4)
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1
University of California San Francisco- Fresno
Fresno, California, United States, 93701
2
Indiana University
Indianapolis, Indiana, United States, 46202
3
Kansas University Medical Center Research Institute, Inc
Kansas City, Kansas, United States, 66160
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425