Rupture of Fetal Membranes
Conditions
Keywords
ROM, PROM, PPROM (preterm premature rupture of membranes)
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 is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.
Interventions
DEVICEAmniSure ROM test
Comparison of AmniSure ROM test to clinical diagnosis of ROM.
Sponsors
QIAGEN Gaithersburg, Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes. | One time at time of enrollment | The investigational AmniSure ROM test will be compared to the three standard tests of nitrazine, ferning and pooling to determine rupture of fetal membranes. |
Countries
United States
Outcome results
None listed