Evaluation of the Safety and Performance of Centaflow as a Routine Assessment of Placental Vascular Function and Foetal Cardiovascular Health
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,704
- 试验地点
- 2
- 主要终点
- Fetal Growth Restriction (FGR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Fetal abnormality known to affect growth, diagnosed in-utero or through 12 days postnatally.
研究组 & 干预措施
Standard Care
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.
干预措施: Standard Care (Diagnostic Test)
Standard Care and Centaflow
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.
干预措施: Centaflow and Standard Care (Device)
结局指标
主要结局
Fetal Growth Restriction (FGR)
时间窗: 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
时间窗: At gestational week 37-39
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
Safety: occurrence of device-related adverse events
时间窗: At gestational week 27-29
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
Safety: occurrence of device-related adverse events
时间窗: At gestational week 34-36
Outcome is the occurrence of device-related adverse events and their classification as serious or not.
次要结局
- Mode of delivery(At birth)
- Neonatal Intensive Care Unit(At 12 days postpartum)