Back to results

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

Primary Purpose

Intra-Amniotic Infection of Foetus

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Perilynx Analyzer to measure AF and VF fluid

About this trial

This is an interventional diagnostic trial for Intra-Amniotic Infection of Foetus

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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:
1. Cervical dilation > 2cm
2. 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

Sites / Locations

Good Samaritan Hospital
Willis Knighton
Rutgers
Ohio State Medical Center
Regional Obstetrical Consultants

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All women eligible to participate

Arm 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

Outcomes

Primary Outcome Measures

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.

performance of amniocentesis test

To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI).

Secondary Outcome Measures

Full Information

NCT ID

NCT03497234

First Posted

April 3, 2018

Last Updated

July 26, 2018

Sponsor

Hologic, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03497234

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Business Strategic Decision

Study Start Date

March 28, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hologic, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intra-Amniotic Infection of Foetus

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

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

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All women eligible to participate

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Perilynx Analyzer to measure AF and VF fluid

Intervention Description

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

Primary Outcome Measure Information:

Title

performance of vaginal fluid test

Description

To assess the performance of a vaginal fluid test for assessing risk of IAI in subjects presenting with preterm labor and intact membranes.

Time Frame

18 months

Title

performance of amniocentesis test

Description

To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI).

Time Frame

18 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina Mastandrea

Organizational Affiliation

Hologic, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Good Samaritan Hospital

City

Long Beach

State/Province

California

ZIP/Postal Code

95142

Country

United States

Facility Name

Willis Knighton

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71118

Country

United States

Facility Name

Rutgers

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Facility Name

Ohio State Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Regional Obstetrical Consultants

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

07102

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs