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

Intra-Amniotic Infection of Foetus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03497234
• Other study ID #: D0116003
• Status: Withdrawn
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2018
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Intra-Amniotic Infection of Foetus

Intervention

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.

Locations

Country	Name	City	State
United States	Regional Obstetrical Consultants	Chattanooga	Tennessee
United States	Ohio State Medical Center	Columbus	Ohio
United States	Good Samaritan Hospital	Long Beach	California
United States	Rutgers	Newark	New Jersey
United States	Willis Knighton	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	performance of amniocentesis test	To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI).	18 months