Clinical Evaluation of the AmniSure ROM Test

Qiagen

Status: Terminated

Conditions: Rupture of Fetal Membranes

Treatments: Device: AmniSure ROM test

Study type: Observational

Funder types: Industry

Identifiers

NCT01847820

C13-ROM-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 383 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

383 participants in 1 patient group

Symptomatic

Description:

Individuals with signs, symptoms or suspicion of membrane rupture at 11 to 42 weeks gestation that will receive the AmniSure ROM test.

Treatment:

Device: AmniSure ROM test