Study Title
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
Purpose
To collect clinical specimens and corresponding clinical data to assess the performance of a rapid amniotic fluid test (AF) and a non-invasive vaginal fluid (VF) test for detection of intra-amniotic infection and prediction of preterm birth
Eligibility
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
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
CAN NOT:
Have documented ruptured amniotic membranes
Be pregnant with a fetus with major fetal or genetic anomaly or chromosomal aneuploidy
Have maternal or fetal indication for preterm birth (e.g., pre-eclampsia)
Have evidence of non-reassuring fetal heart rate tracing requiring immediate delivery
Have vaginal bleeding within the past 24 hours · Have advanced labor (cervix >4 cm dilated) · Have HIV or hepatitis
Study Process
Stipend: $ 125.00
Trial Details
Investigator:
Christian Briery, M.D.
IRB:
CGIRB
IRB Number:
Trial Type:
Drug
Sponsor:
Hologic
Contact Information:
Regional Perinatal Group
(318) 212-8130
Regionalperinatalgroup.com