Evaluation of the Safety and Performance of Centaflow
Fetal Growth Restriction
About this trial
This is an interventional diagnostic trial for Fetal Growth Restriction
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.
Sites / Locations
- Juliane Marie Centeret, RigshospitaletRecruiting
- Obstetrical Department, Regional Hospital ViborgRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Care
Standard Care and Centaflow
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.