Evaluation of the Safety and Performance of Centaflow

Centaflow

Status: Unknown

Conditions: Fetal Growth Restriction

Treatments: Device: Centaflow and Standard Care; Diagnostic Test: Standard Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04438668

2019-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,704 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,704 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

Standard care (SC) for screening for FGR is a healthcare provider auscultating the foetal heart rate with a standard stethoscope, palpation of foetal size by hand, and measuring the size of the woman's uterus with a tape measure, and comparing the measurement to the expected measurement for the gestational age of the foetus.

Treatment:

Diagnostic Test: Standard Care

Standard Care and Centaflow

Experimental group

Description:

Centaflow uses sound-derived maternal intra-arterial turbulence as a marker of foetal growth restriction (FGR) and provides information on the foetal heart rate. Indication for use is as a screening device for FGR in women beyond 27 weeks of pregnancy with a singleton pregnancy.

Treatment:

Device: Centaflow and Standard Care