Evaluation of the Safety and Performance of Centaflow

NCT ID: NCT04438668

Last Updated: 2022-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1704 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-03

Study Completion Date

2022-06-30

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.

Conditions

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Fetal Growth Restriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Controlled Trial
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type DIAGNOSTIC_TEST

The intervention is screening methods

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.

Group Type EXPERIMENTAL

Centaflow and Standard Care

Intervention Type DEVICE

The intervention is screening methods

Interventions

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Centaflow and Standard Care

The intervention is screening methods

Intervention Type DEVICE

Standard Care

The intervention is screening methods

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Standard Care is Symphysis-fundal measure and fetal weight estimation Symphysis-fundal measure and fetal weight estimation

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Viborg Regional Hospital

OTHER

Sponsor Role collaborator

Centaflow

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Farlie, MD, MI, MHM

Role: PRINCIPAL_INVESTIGATOR

Viborg Regional Hospital

Locations

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Juliane Marie Centeret, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Obstetrical Department, Regional Hospital Viborg

Viborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Richard Farlie, MD, MI, MHM

Role: CONTACT

+45 78 44 58 63

Olav Bjoern Petersen, Professor, MD

Role: CONTACT

+45 35 45 09 08

Facility Contacts

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Olav Petersen, Professor

Role: primary

+45 35 45 09 08

Richard Farlie, MD

Role: primary

+45 78445863

Other Identifiers

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2019-01

Identifier Type: -

Identifier Source: org_study_id

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