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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04438668
Other study ID # 2019-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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