Evaluation of the Safety and Performance of Centaflow

NCT04438668 | Unknown DMC

• 1 other identifier: 2019-01
• Study Type: interventional
• Target: 1,704
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fetal Growth Restriction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Mode of delivery

  At birth

• Neonatal Intensive Care Unit

  At 12 days postpartum

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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

Standard Care and Centaflow

EXPERIMENTAL

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

Interventions

Centaflow and Standard Care DEVICE

The intervention is screening methods

Also known as: Standard Care is Symphysis-fundal measure and fetal weight estimation

Standard Care and Centaflow

Standard Care DIAGNOSTIC_TEST

The intervention is screening methods

Also known as: Symphysis-fundal measure and fetal weight estimation

Standard Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Centaflow: lead
• Rigshospitalet, Denmark: collaborator
• Viborg Regional Hospital: collaborator

Study Sites (2)

Juliane Marie Centeret, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Obstetrical Department, Regional Hospital Viborg

Viborg, 8800, Denmark

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Farlie, MD, MI, MHM

  Viborg Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Farlie, MD, MI, MHM

CONTACT

+45 78 44 58 63; richard.farlie@midt.rm.dk

Olav Bjoern Petersen, Professor, MD

CONTACT

+45 35 45 09 08; olav.bennike.bjoern.petersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 19, 2020
• Study Start: June 3, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)