Rupture of Fetal Membranes Clinical Trial
Official title:
Clinical Evaluation of the AmniSure ROM Test
| Verified date | July 2016 |
| Source | QIAGEN Gaithersburg, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 383 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | University of California San Francisco- Fresno | Fresno | California |
| United States | Indiana University | Indianapolis | Indiana |
| United States | Kansas University Medical Center Research Institute, Inc | Kansas City | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| QIAGEN Gaithersburg, Inc |
United States,
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* Note: There are 32 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes. | The investigational AmniSure ROM test will be compared to the three standard tests of nitrazine, ferning and pooling to determine rupture of fetal membranes. | One time at time of enrollment | No |