NCT05742997

Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor

Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Currently, the American College of Obstetricians and Gynecologists (ACOG) indicate in their most recent Practice Bulletin on the Management of Preterm Labor that many tests to identify women at risk of preterm birth have been proposed and evaluated; however, only ultrasonography and fetal fibronectin testing have been shown to have benefit. Ultrasonography to determine cervical length, fetal fibronectin testing, or a combination of both may be useful in determining which women are at high risk for preterm delivery. However, their clinical usefulness may rest primarily with their ability to identify women who are least likely to deliver (i.e. their negative predictive value). Therefore, there is an urgent need for a test with a high positive predictive value in order to accurately predict imminent delivery to allow for salutary intervention.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DEVICE	PartoSure	Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1
DEVICE	Fetal Fibronectine	Diagnostic Kit for the Detection of Fetal Fibronectine

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-08-31
• Completion: 2023-10-31
• First posted: 2023-02-24
• Last updated: 2023-02-24

Locations

1 site across 1 country: Belgium