NCT03497234

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intra-Amniotic Infection of Foetus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-28
• Primary completion: 2019-12-31
• Completion: 2020-03-31
• First posted: 2018-04-13
• Last updated: 2018-07-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study