Evaluation of the Safety and Performance of Centaflow

Centaflow1,704 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

1,704

Conditions

Fetal Growth Restriction

Interventions

Centaflow and Standard CareDEVICE

The intervention is screening methods

Standard CareDIAGNOSTIC_TEST

The intervention is screening methods

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Juliane Marie Centeret, Rigshospitalet

Copenhagen, Denmark

RECRUITING

Obstetrical Department, Regional Hospital Viborg

Viborg, Denmark

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At gestational week 37-39

Secondary Outcomes

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.

Time frame: At birth

Neonatal Intensive Care Unit

Outcome is the occurrence of admission to the Neonatal Intensive Care Unit

Time frame: At 12 days postpartum

Central 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

Data from ClinicalTrials.gov

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