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

Hologic

Status: Withdrawn

Conditions: Intra-Amniotic Infection of Foetus

Treatments: Diagnostic Test: Perilynx Analyzer to measure AF and VF fluid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03497234

D0116003

Details and patient eligibility

About

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).

Full 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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

All women eligible to participate

Experimental group

Description:

All women presenting who sign the consent and found eligible will have a VF and AF sample taken and analyzed on the Perilynx Analyzer to measure AF and VF fluid. This does not affect their regular standard of care and diagnosis

Treatment:

Diagnostic Test: Perilynx Analyzer to measure AF and VF fluid