Development of a Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test to Detect Intra-Amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and Intact Amniotic Membranes
Development of a Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test to Detect Intra-Amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and Intact Amniotic Membranes
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.
Inclusion Criteria:
Subject is ≥ 18 years of age
Subject has singleton gestation
Subject has fetus with gestational age ≥ 22 0/7 weeks and ≤ 33 6/7 weeks
Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (≥4 per hour) and one or more of the following:
Subject has onset of contractions was within 48 hours of enrollment in the study
Subject has documented intact amniotic membranes
Subject's care provider plans to perform an amniocentesis procedure -
Exclusion Criteria: