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

Not Applicable

Withdrawn

• Conditions: Intra-Amniotic Infection of Foetus
• Interventions: Diagnostic Test: Perilynx Analyzer to measure AF and VF fluid

• Registration Number: NCT03497234
• Lead Sponsor: Hologic, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-03-28
• Status Verified: 2018-04
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-30
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All women eligible to participate	Perilynx Analyzer to measure AF and VF fluid	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

Primary Outcome Measures

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

Trial Locations

Locations (5)

Good Samaritan Hospital; 🇺🇸 Long Beach, California, United States

Regional Obstetrical Consultants; 🇺🇸 Chattanooga, Tennessee, United States

Willis Knighton; 🇺🇸 Shreveport, Louisiana, United States

Rutgers; 🇺🇸 Newark, New Jersey, United States

Ohio State Medical Center; 🇺🇸 Columbus, Ohio, United States