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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Growth Restriction
• Intervention / Treatment: Diagnostic test: Standard Care; Device: Centaflow and Standard Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1704
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard Farlie, MD, MI, MHM; Phone Number: +45 78 44 58 63; Email: richard.farlie@midt.rm.dk
• Study Contact Backup: Name: Olav Bjoern Petersen, Professor, MD; Phone Number: +45 35 45 09 08; Email: olav.bennike.bjoern.petersen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Juliane Marie Centeret, Rigshospitalet
    • Contact: Olav Petersen, Professor; Phone Number: +45 35 45 09 08; Email: olav.bennike.bjoern.petersen@regionh.dk
  • Viborg, Denmark, 8800
    • Recruiting
    • Obstetrical Department, Regional Hospital Viborg
    • Contact: Richard Farlie, MD; Phone Number: +45 78445863; Email: richard.farlie@midt.rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; 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; The intervention is screening methods; Other Names: Symphysis-fundal measure and fetal weight estimation
Experimental: Standard Care and Centaflow; 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; The intervention is screening methods; Other Names: Standard Care is Symphysis-fundal measure and fetal weight estimation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centaflow
• Collaborators: Rigshospitalet, Denmark; Viborg Regional Hospital
• Investigators: Principal Investigator: Richard Farlie, MD, MI, MHM, Viborg Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: 2019-01 (Other Identifier: NANT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Sharing raw data is inconsistent with the ethics application form and the participant informed consent materials.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No