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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-28

Study Completion Date

2020-03-31

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).

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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.

Conditions

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Intra-Amniotic Infection of Foetus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Investigator is blinded to results of the analyzer but all patients have samples run on analyzer

Study Groups

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All women eligible to participate

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

Group Type EXPERIMENTAL

Perilynx Analyzer to measure AF and VF fluid

Intervention Type DIAGNOSTIC_TEST

Hologic developed a rapid in-vitro diagnostic system composed of an analyzer and cassettes to identify women with intra-amniotic infection.

Interventions

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Perilynx Analyzer to measure AF and VF fluid

Hologic developed a rapid in-vitro diagnostic system composed of an analyzer and cassettes to identify women with intra-amniotic infection.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No