Clinical Evaluation of the AmniSure ROM Test

Stopped early

Conditions studied: Rupture of Fetal Membranes

In brief

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.

Key facts

Study ID

NCT01847820

Run by

QIAGEN Gaithersburg, Inc

People needed

383

Starts

2013-08-01

Expected to finish

2016-07-01

Last updated by the study team

2016-07-14

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects who have placenta previa.
• Subjects who have heavy vaginal bleeding.
• Subjects who have had digital vaginal examination immediately prior to evaluation for ROM.

Where it is running

• 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, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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