Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03497234
Recruitment Status : Withdrawn (Business Strategic Decision)
First Posted : April 13, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Intra-Amniotic Infection of Foetus Diagnostic Test: Perilynx Analyzer to measure AF and VF fluid Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention 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
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

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.




Primary Outcome Measures :
  1. performance of vaginal fluid test [ Time Frame: 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.

  2. performance of amniocentesis test [ Time Frame: 18 months ]
    To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497234


Locations
Layout table for location information
United States, California
Good Samaritan Hospital
Long Beach, California, United States, 95142
United States, Louisiana
Willis Knighton
Shreveport, Louisiana, United States, 71118
United States, New Jersey
Rutgers
Newark, New Jersey, United States, 07102
United States, Ohio
Ohio State Medical Center
Columbus, Ohio, United States, 43210
United States, Tennessee
Regional Obstetrical Consultants
Chattanooga, Tennessee, United States, 07102
Sponsors and Collaborators
Hologic, Inc.
Investigators
Layout table for investigator information
Study Director: Christina Mastandrea Hologic, Inc.

Layout table for additonal information
Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT03497234    
Other Study ID Numbers: D0116003
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
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.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection