Clinical trial NCT03497234: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Intra-Amniotic Infection of Foetus
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: performance of vaginal fluid test
timeFrame: 18 months
measure: performance of amniocentesis test
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Good Samaritan Hospital
state: California
city: Shreveport
country: United States
facility: Willis Knighton
state: Louisiana
city: Newark
country: United States
facility: Rutgers
state: New Jersey
city: Columbus
country: United States
facility: Ohio State Medical Center
state: Ohio
city: Chattanooga
country: United States
facility: Regional Obstetrical Consultants
state: Tennessee
Study officials:
affiliation: Hologic, Inc.
name: Christina Mastandrea
role: STUDY_DIRECTOR
References: