Clinical trial NCT01847820: Clinical Evaluation of the AmniSure ROM Test
Official title: Clinical Evaluation of the AmniSure ROM Test
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rupture of Fetal Membranes
Keywords: ROM
PROM
PPROM (preterm premature rupture of membranes)
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 383
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be women presenting with signs, symptoms or suspicion of membrane rupture at 11 to 42 weeks gestation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The evaluation the clinical performance of the AmniSure® ROM test performed by the Intended-User relative to the clinical diagnosis of rupture of membranes.
timeFrame: One time at time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: University of California San Francisco- Fresno
state: California
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center Research Institute, Inc
state: Kansas
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
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