Not provided
Not provided
Not provided
Not provided
Not provided
Business Strategic Decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All women eligible to participate | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perilynx Analyzer to measure AF and VF fluid | Diagnostic Test | Hologic developed a rapid in-vitro diagnostic system composed of an analyzer and cassettes to identify women with intra-amniotic infection. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| performance of amniocentesis test | To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI). | 18 months |
Not provided
Not provided
Inclusion Criteria:
Subject is ≥ 18 years of age
Subject has singleton gestation
Subject has fetus with gestational age ≥ 22 0/7 weeks and ≤ 33 6/7 weeks
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:
Subject has onset of contractions was within 48 hours of enrollment in the study
Subject has documented intact amniotic membranes
Subject's care provider plans to perform an amniocentesis procedure -
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christina Mastandrea | Hologic, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | Long Beach | California | 95142 | United States | ||
| Willis Knighton |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit
Not provided
Not provided
Investigator is blinded to results of the analyzer but all patients have samples run on analyzer
Not provided
| Shreveport |
| Louisiana |
| 71118 |
| United States |
| Rutgers | Newark | New Jersey | 07102 | United States |
| Ohio State Medical Center | Columbus | Ohio | 43210 | United States |
| Regional Obstetrical Consultants | Chattanooga | Tennessee | 07102 | United States |