Status:
UNKNOWN
Evaluation of the Safety and Performance of Centaflow
Lead Sponsor:
Centaflow
Collaborating Sponsors:
Rigshospitalet, Denmark
Viborg Regional Hospital
Conditions:
Fetal Growth Restriction
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 g...
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 preg...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
1704 Patients enrolled
Trial Details
Trial ID
NCT04438668
Start Date
June 3 2020
End Date
June 30 2022
Last Update
June 10 2022
Active Locations (2)
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1
Juliane Marie Centeret, Rigshospitalet
Copenhagen, Denmark, 2100
2
Obstetrical Department, Regional Hospital Viborg
Viborg, Denmark, 8800