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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03497234
Other study ID # D0116003
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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