Fetal Growth Restriction
Conditions
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 growth restriction.
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 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.
Interventions
DEVICECentaflow and Standard Care
The intervention is screening methods
DIAGNOSTIC_TESTStandard Care
The intervention is screening methods
Sponsors
Rigshospitalet, Denmark
Viborg Regional Hospital
Centaflow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomised Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Growth Restriction (FGR) | At birth | 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. |
| Safety: occurrence of device-related adverse events | At gestational week 27-29 | Outcome is the occurrence of device-related adverse events and their classification as serious or not. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | At birth | Outcome is the mode of delivery being either A) uncomplicated vaginal, B) complicated vaginal, C) planned cesarean section or D) emergency cesarean section. |
| Neonatal Intensive Care Unit | At 12 days postpartum | Outcome is the occurrence of admission to the Neonatal Intensive Care Unit |
Countries
Denmark
Contacts
Primary ContactRichard Farlie, MD, MI, MHM
Backup ContactOlav Bjoern Petersen, Professor, MD
Outcome results
None listed