A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected Intra-Amniotic Infection (IAI).
A study on patients in preterm labor for whom the managing physician plans to perform amniocentesis to evaluate for possible infection using conventional, currently available methods. Vaginal fluid will be collected and analyzed and amniotic fluid will also. These tests will be run remotely and not reported to the clinician.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Hologic developed a rapid in-vitro diagnostic system composed of an analyzer and cassettes to identify women with intra-amniotic infection.
Good Samaritan Hospital
Long Beach, California, United States
Willis Knighton
Shreveport, Louisiana, United States
Rutgers
Newark, New Jersey, United States
Ohio State Medical Center
Columbus, Ohio, United States
performance of vaginal fluid test
To assess the performance of a vaginal fluid test for assessing risk of IAI in subjects presenting with preterm labor and intact membranes.
Time frame: 18 months
performance of amniocentesis test
To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI).
Time frame: 18 months
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Regional Obstetrical Consultants
Chattanooga, Tennessee, United States