- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438668
Evaluation of the Safety and Performance of Centaflow
Evaluation of the Safety and Performance of Centaflow as a Routine Assessment of Placental Vascular Function and Foetal Cardiovascular Health
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Richard Farlie, MD, MI, MHM
- Phone Number: +45 78 44 58 63
- Email: richard.farlie@midt.rm.dk
Study Contact Backup
- Name: Olav Bjoern Petersen, Professor, MD
- Phone Number: +45 35 45 09 08
- Email: olav.bennike.bjoern.petersen@regionh.dk
Study Locations
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Copenhagen, Denmark, 2100
- Recruiting
- Juliane Marie Centeret, Rigshospitalet
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Contact:
- Olav Petersen, Professor
- Phone Number: +45 35 45 09 08
- Email: olav.bennike.bjoern.petersen@regionh.dk
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Viborg, Denmark, 8800
- Recruiting
- Obstetrical Department, Regional Hospital Viborg
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Contact:
- Richard Farlie, MD
- Phone Number: +45 78445863
- Email: richard.farlie@midt.rm.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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The intervention is screening methods
Other Names:
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Experimental: 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.
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The intervention is screening methods
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fetal Growth Restriction (FGR)
Time Frame: At birth
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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.
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At birth
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Safety: occurrence of device-related adverse events
Time Frame: At gestational week 27-29
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Outcome is the occurrence of device-related adverse events and their classification as serious or not.
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At gestational week 27-29
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Safety: occurrence of device-related adverse events
Time Frame: At gestational week 34-36
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Outcome is the occurrence of device-related adverse events and their classification as serious or not.
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At gestational week 34-36
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Safety: occurrence of device-related adverse events
Time Frame: At gestational week 37-39
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Outcome is the occurrence of device-related adverse events and their classification as serious or not.
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At gestational week 37-39
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mode of delivery
Time Frame: At birth
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Outcome is the mode of delivery being either A) uncomplicated vaginal, B) complicated vaginal, C) planned cesarean section or D) emergency cesarean section.
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At birth
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Neonatal Intensive Care Unit
Time Frame: At 12 days postpartum
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Outcome is the occurrence of admission to the Neonatal Intensive Care Unit
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At 12 days postpartum
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Farlie, MD, MI, MHM, Viborg Regional Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-01 (Other Identifier: NANT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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