UnknownNot Applicable

Evaluation of the Safety and Performance of Centaflow

Denmark1,704 participantsStarted 2020-06-03

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Fetal Growth Restriction (FGR)

Timeframe: At birth

Safety: occurrence of device-related adverse events

Timeframe: At gestational week 27-29

Safety: occurrence of device-related adverse events

Timeframe: At gestational week 34-36

Safety: occurrence of device-related adverse events

Timeframe: At gestational week 37-39

Trial details

NCT IDNCT04438668

SponsorCentaflow

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-30

Contact for this trial

Richard Farlie, MD, MI, MHM

+45 78 44 58 63 richard.farlie@midt.rm.dk

View on ClinicalTrials.gov More Fetal Growth Restriction trials