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

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.

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.

Inclusion Criteria

• Female subjects over the age of 18 years.
• Subejct is pregnant, carries only one fetus and has been pregnancy dated by ultrasound scan (Hadlock reference).

Exclusion Criteria

• Fetal abnormality known to affect growth, diagnosed in-utero or through 12 days postnatally.