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

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:

1. Subject is ≥ 18 years of age

2. Subject has singleton gestation

3. Subject has fetus with gestational age ≥ 22 0/7 weeks and ≤ 33 6/7 weeks

4. 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:

1. Cervical dilation > 2cm

2. Cervical length of ≤25 mm via transvaginal ultrasound

5. Subject has onset of contractions was within 48 hours of enrollment in the study

6. Subject has documented intact amniotic membranes

7. Subject's care provider plans to perform an amniocentesis procedure -

Exclusion Criteria:

- 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