Amnisure: Detection and Stratification of Patients at Risk for Preterm Delivery

Service: Trial Number:
102-12
Principal Investigator: Conducted at:
Long Beach Memorial, Miller Children's & Women's Hospital Long Beach
Currently enrolling additional patients:
Yes

Preterm delivery is a major cause of neonatal morbidity and mortality. Patients commonly present during pregnancy with signs or symptoms of preterm labor and many will go on to deliver at term. Current methods of predicting which patients will deliver prematurely are limited and there are no tests that currently identify which patients may benefit from a particular treatment. Amnisure is an FDA approved rapid strip test designed to detect ruptured membranes. The test has been shown to have a sensitivity of >99%, but a few false positives have been reported. Subsequently, two studies evaluating this test in patients, with clinically intact membranes, have demonstrated that the subset of patients with a positive test result were significantly more likely to experience rupture of the membranes or delivery sooner than those with a negative result. The test has not been evaluated in the setting of threatened preterm labor. The purpose of this study is to evaluate this test in patients presenting with symptoms of premature labor to determine if is useful in identifying which patients are more likely to deliver prematurely. This is a prospective observational study of pregnant patients presenting to labor and delivery with symptoms of preterm labor. Patients being evaluated in triage for symptoms of preterm labor and admitted for threatened preterm labor, who agree to participate, will have the Amnisure test performed with the physicians blinded to the results. The time from the test being performed until delivery will be the primary outcome and subjects with a positive result will comprise one group and be compared to those with a negative result.

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