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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Intra-Amniotic Infection of Foetus

Intervention / Treatment
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* Diagnostic Test: Perilynx Analyzer to measure AF and VF fluid


Participation Criteria
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Eligibility Criteria
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Inclusion 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) 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 - 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All women eligible to participate<br>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 | Diagnostic Test: Perilynx Analyzer to measure AF and VF fluid<br>* Hologic developed a rapid in-vitro diagnostic system composed of an analyzer and cassettes to identify women with intra-amniotic infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance of vaginal fluid test | To assess the performance of a vaginal fluid test for assessing risk of IAI in subjects presenting with preterm labor and intact membranes. | 18 months | 
| performance of amniocentesis test | To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI). | 18 months |