Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test

Withdrawn before enrolling · Not applicable

Conditions studied: Intra-Amniotic Infection of Foetus

In brief

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).

Key facts

Study ID

NCT03497234

Run by

Hologic, Inc.

People needed

0

Starts

2018-03-28

Expected to finish

2020-03-31

Last updated by the study team

2018-07-30

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 1. 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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