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

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

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

Details

Stipend: $ 125.00

Interested in more information? Contact Us:

Christian Briery, M.D., Principal Investigator
Regional Perinatal Group
(318) 212-8130

IRB: CGIRB
IRB Number:
Trial Type: Drug
Sponsor: Hologic