Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test
- Conditions
- Intra-Amniotic Infection of Foetus
- Registration Number
- NCT03497234
- Lead Sponsor
- Hologic, Inc.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
-
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:
- Cervical dilation > 2cm
- Cervical length of ≤25 mm via transvaginal ultrasound
-
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 -
-
- Subject has documented ruptured amniotic membranes 2. Subject has a fetus with major fetal or genetic anomaly or chromosomal aneuploidy 3. Subject has maternal or fetal indication for preterm birth (e.g., pre-eclampsia) 4. Subject is unable to provide written informed consent 5. Subject has evidence of non-reassuring fetal heart rate tracing requiring immediate delivery 6. Subject has vaginal bleeding within the past 24 hours 7. Subject has advanced labor (cervix >4 cm dilated) 8. Subject has HIV, hepatitis 9. Subject has not been enrolled previously in this study and/or is participating in another study (that in the opinion of the Investigator) may interfere with participation in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method performance of vaginal fluid test 18 months To assess the performance of a vaginal fluid test for assessing risk of IAI in subjects presenting with preterm labor and intact membranes.
performance of amniocentesis test 18 months To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
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
Regional Obstetrical Consultants
🇺🇸Chattanooga, Tennessee, United States
Good Samaritan Hospital🇺🇸Long Beach, California, United States