NCT04438668

Evaluation of the Safety and Performance of Centaflow

Evaluation of the Safety and Performance of Centaflow as a Routine Assessment of Placental Vascular Function and Foetal Cardiovascular Health

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,704 (estimated)
• Sponsor: Centaflow · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the safety and performance of an acoustic approach based on skin-contact microphones as a routine assessment of placental vascular function as predictor of fetal growth restriction.

Detailed description

Evaluation of the safety and performance of Centaflow as routine antenatal assessment of placental vascular function as predictor of fetal growth restriction is performed by randomizing singleton pregnant women with ultrasound-based gestations for either standard care (SC) or SC and Centaflow (CF). The subjects will be randomized in ratio 1:1 in both groups and examined in pregnancy weeks 27-29, 34-36 and 37-39.

Conditions

• Fetal Growth Restriction

Interventions

Type	Name	Description
DEVICE	Centaflow and Standard Care	The intervention is screening methods
DIAGNOSTIC_TEST	Standard Care	The intervention is screening methods

Timeline

• Start date: 2020-06-03
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-06-19
• Last updated: 2022-06-10

Locations

2 sites across 1 country: Denmark