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Evaluation of the Safety and Performance of Centaflow

Primary Purpose

Fetal Growth Restriction

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Centaflow and Standard Care
Standard Care
Sponsored by
Centaflow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fetal Growth Restriction

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Juliane Marie Centeret, RigshospitaletRecruiting
  • Obstetrical Department, Regional Hospital ViborgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

Standard Care and Centaflow

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Safety: occurrence of device-related adverse events
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
Safety: occurrence of device-related adverse events
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
Safety: occurrence of device-related adverse events
Outcome is the occurrence of device-related adverse events and their classification as serious or not.

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2020
Last Updated
June 9, 2022
Sponsor
Centaflow
Collaborators
Rigshospitalet, Denmark, Viborg Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04438668
Brief Title
Evaluation of the Safety and Performance of Centaflow
Official Title
Evaluation of the Safety and Performance of Centaflow as a Routine Assessment of Placental Vascular Function and Foetal Cardiovascular Health
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centaflow
Collaborators
Rigshospitalet, Denmark, Viborg Regional Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Restriction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1704 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Care and Centaflow
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Centaflow and Standard Care
Other Intervention Name(s)
Standard Care is Symphysis-fundal measure and fetal weight estimation
Intervention Description
The intervention is screening methods
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard Care
Other Intervention Name(s)
Symphysis-fundal measure and fetal weight estimation
Intervention Description
The intervention is screening methods
Primary Outcome Measure Information:
Title
Fetal Growth Restriction (FGR)
Description
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
Title
Safety: occurrence of device-related adverse events
Description
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
Time Frame
At gestational week 27-29
Title
Safety: occurrence of device-related adverse events
Description
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
Time Frame
At gestational week 34-36
Title
Safety: occurrence of device-related adverse events
Description
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
Time Frame
At gestational week 37-39
Secondary Outcome Measure Information:
Title
Mode of delivery
Description
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
Title
Neonatal Intensive Care Unit
Description
Outcome is the occurrence of admission to the Neonatal Intensive Care Unit
Time Frame
At 12 days postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Farlie, MD, MI, MHM
Phone
+45 78 44 58 63
Email
richard.farlie@midt.rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Olav Bjoern Petersen, Professor, MD
Phone
+45 35 45 09 08
Email
olav.bennike.bjoern.petersen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Farlie, MD, MI, MHM
Organizational Affiliation
Viborg Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juliane Marie Centeret, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olav Petersen, Professor
Phone
+45 35 45 09 08
Email
olav.bennike.bjoern.petersen@regionh.dk
Facility Name
Obstetrical Department, Regional Hospital Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Farlie, MD
Phone
+45 78445863
Email
richard.farlie@midt.rm.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Sharing raw data is inconsistent with the ethics application form and the participant informed consent materials.

Learn more about this trial

Evaluation of the Safety and Performance of Centaflow

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