Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Viborg Regional Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | 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. |
|
| Standard Care and Centaflow | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centaflow and Standard Care | Device | The intervention is screening methods |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Neonatal Intensive Care Unit |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Farlie, MD, MI, MHM | Contact | +45 78 44 58 63 | richard.farlie@midt.rm.dk | |
| Olav Bjoern Petersen, Professor, MD | Contact | +45 35 45 09 08 | olav.bennike.bjoern.petersen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Richard Farlie, MD, MI, MHM | Viborg Regional Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juliane Marie Centeret, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
Sharing raw data is inconsistent with the ethics application form and the participant informed consent materials.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Randomised Controlled Trial
Not provided
Not provided
Not provided
| Standard Care | Diagnostic Test | The intervention is screening methods |
|
|
Outcome is the occurrence of admission to the Neonatal Intensive Care Unit
| At 12 days postpartum |
| Obstetrical Department, Regional Hospital Viborg | Recruiting | Viborg | 8800 | Denmark |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |