Fetal Growth RestrictionNCT04438668
Evaluation of the Safety and Performance of Centaflow
A study of Fetal Growth Restriction, run by Centaflow at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,704 participants
- Where
- 2 sitesDenmark
- Study dates
- 3 Jun 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Fetal abnormality known to affect growth, diagnosed in-utero or through 12 days postnatally.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Juliane Marie Centeret, Rigshospitalet
Copenhagen, 2100
Olav Petersen, Professor, +45 35 45 09 08, olav.bennike.bjoern.petersen@regionh.dk
- Recruiting
Obstetrical Department, Regional Hospital Viborg
Viborg, 8800
Richard Farlie, MD, +45 78445863, richard.farlie@midt.rm.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Growth Restriction
- Being tested
- Centaflow and Standard Care, Standard Care
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centaflow and Standard CareDevice
Also called Standard Care is Symphysis-fundal measure and fetal weight estimation
The intervention is screening methods
Standard CareDiagnostic test
Also called Symphysis-fundal measure and fetal weight estimation
The intervention is screening methods
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Centaflow and Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At gestational week 37-39
Secondary outcomes (2)
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.
Measured: At birth
Neonatal Intensive Care Unit
Outcome is the occurrence of admission to the Neonatal Intensive Care Unit
Measured: At 12 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start3 Jun 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,704 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centaflow
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Viborg Regional Hospital
- Responsible party
- Sponsor
- Investigators
- Richard Farlie, MD, MI, MHM, Principal investigator, Viborg Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438668
- Sponsor's protocol ID
- 2019-01
- Status last verified
- Dec 2021
- First submitted
- 8 Jun 2020
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing raw data is inconsistent with the ethics application form and the participant informed consent materials.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of Centaflow as a Routine Assessment of Placental Vascular Function and Foetal Cardiovascular Health
- ClinicalTrials.gov ID
- NCT04438668
- Acronym / sponsor ID
- 2019-01
- Conditions
- Fetal Growth Restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,704 participants (estimated)
- Lead sponsor
- CentaflowIndustry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Viborg Regional Hospital
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Diagnostic Test: Standard CareStandard 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. |
| Standard Care and Centaflow | Experimental | Device: Centaflow and Standard CareCentaflow 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Fetal abnormality known to affect growth, diagnosed in-utero or through 12 days postnatally.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centaflow and Standard CareAlso: Standard Care is Symphysis-fundal measure and fetal weight estimationThe intervention is screening methods | Device | Standard Care and Centaflow |
| Standard CareAlso: Symphysis-fundal measure and fetal weight estimationThe intervention is screening methods | Diagnostic test | Standard Care |
Primary outcome
Fetal Growth Restriction (FGR)
Time frame: At birth
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
Time frame: At gestational week 27-29
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
Safety: occurrence of device-related adverse events
Time frame: At gestational week 34-36
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
Safety: occurrence of device-related adverse events
Time frame: At gestational week 37-39
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
2 secondary outcomes
Mode of delivery
Time frame: At birth
Neonatal Intensive Care Unit
Time frame: At 12 days postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No. Sharing raw data is inconsistent with the ethics application form and the participant informed consent materials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Farlie, MD, MI, MHM principal investigator
Viborg Regional Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fetal Growth Restriction, run by Centaflow at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Farlie, MD, MI, MHM (+45 78 44 58 63, richard.farlie@midt.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal Growth Restriction (FGR) (time frame: At birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.