Intra-Amniotic Infection of Foetus
Conditions
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.
Interventions
DIAGNOSTIC_TESTPerilynx 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.
Sponsors
Hologic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Investigator is blinded to results of the analyzer but all patients have samples run on analyzer
Intervention model description
This is a multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| performance of vaginal fluid test | 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. |
| performance of amniocentesis test | 18 months | To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI). |
Countries
United States
Outcome results
None listed