Evaluation of the Safety and Performance of Centaflow

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fetal Growth Restriction

Intervention / Treatment
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* Device: Centaflow and Standard Care
* Diagnostic Test: Standard Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>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. | Diagnostic Test: Standard Care<br>* The intervention is screening methods<br>* Other names: Symphysis-fundal measure and fetal weight estimation;|
| Experimental: Standard Care and Centaflow<br>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. | Device: Centaflow and Standard Care<br>* The intervention is screening methods<br>* Other names: Standard Care is Symphysis-fundal measure and fetal weight estimation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Growth Restriction (FGR) | Outcome is the classification of each neonate as FGR or as non-FGR at birth. FGR is defined as birth weight below the 3rd percentile or birth weight below the 10th percentile and an antenatally detected abnormal umbilical artery blood flow. | At birth | 
| Safety: occurrence of device-related adverse events | Outcome is the occurrence of device-related adverse events and their classification as serious or not. | At gestational week 27-29 | 
| Safety: occurrence of device-related adverse events | Outcome is the occurrence of device-related adverse events and their classification as serious or not. | At gestational week 34-36 | 
| Safety: occurrence of device-related adverse events | Outcome is the occurrence of device-related adverse events and their classification as serious or not. | At gestational week 37-39 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | Outcome is the mode of delivery being either A) uncomplicated vaginal, B) complicated vaginal, C) planned cesarean section or D) emergency cesarean section. | At birth | 
| Neonatal Intensive Care Unit | Outcome is the occurrence of admission to the Neonatal Intensive Care Unit | At 12 days postpartum |