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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Intra-Amniotic Infection of Foetus
• Intervention / Treatment: Diagnostic test: Perilynx Analyzer to measure AF and VF fluid

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 95142
      • Good Samaritan Hospital
  • Louisiana
    • Shreveport, Louisiana, United States, 71118
      • Willis Knighton
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Rutgers
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 07102
      • Regional Obstetrical Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Diagnostic test: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hologic, Inc.
• Investigators: Study Director: Christina Mastandrea, Hologic, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: D0116003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No