Evaluation of the Safety and Performance of Centaflow

Fetal Growth Restriction Clinical Trial

Official title:

Evaluation of the Safety and Performance of Centaflow as a Routine Assessment of Placental Vascular Function and Foetal Cardiovascular Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438668
• Other study ID #: 2019-01
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2021
• Source: Centaflow
• Contact: Richard Farlie, MD, MI, MHM
• Phone: +45 78 44 58 63
• Email: richard.farlie[@]midt.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1704
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation

Intervention

Device:
• Centaflow and Standard Care
The intervention is screening methods

Diagnostic Test:
• Standard Care
The intervention is screening methods

Locations

Country	Name	City	State
Denmark	Juliane Marie Centeret, Rigshospitalet	Copenhagen
Denmark	Obstetrical Department, Regional Hospital Viborg	Viborg

Sponsors (3)

Lead Sponsor	Collaborator
Centaflow	Regional Hospital Viborg, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At birth
Primary	Safety: occurrence of device-related adverse events	Outcome is the occurrence of device-related adverse events and their classification as serious or not.	At gestational week 27-29
Primary	Safety: occurrence of device-related adverse events	Outcome is the occurrence of device-related adverse events and their classification as serious or not.	At gestational week 34-36
Primary	Safety: occurrence of device-related adverse events	Outcome is the occurrence of device-related adverse events and their classification as serious or not.	At gestational week 37-39
Secondary	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.	At birth
Secondary	Neonatal Intensive Care Unit	Outcome is the occurrence of admission to the Neonatal Intensive Care Unit	At 12 days postpartum