跳至主要内容
临床试验/NCT05423665
NCT05423665招募中不适用

Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth in Twin Pregnancies

University Hospital, Ghent3 个研究点 分布在 2 个国家目标入组 360 人开始时间: 2023年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
3
主要终点
To compare the strain values (cardiac remodeling) between singletons and twin pregnancies

研究概览

简要总结

In this project there are 2 time points during the pregnancy included, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. The fetal growth parameters will be collected at the same time points, to define the growth (differences) throughout gestation of both fetuses. A maternal blood sample will be taken at 21 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.

详细描述

Fetal growth restriction (FGR) is diagnosed in 5-10% of the pregnancies. After preterm birth, it is the second leading cause of perinatal morbidity and mortality. Twin pregnancies have a higher occurrence of FGR than singletons, in monochorionic (MC) twin pregnancies it's diagnosed in 19.7% of the cases and in dichorionic (DC) twin pregnancies in 10.5% of the cases. Fetuses with FGR are at greater risk of perinatal morbidity and mortality and even long-term health defects. From a public health perspective, it's important to correctly diagnose FGR to adjust the antenatal and postnatal care and to have more insight into the factors influencing early onset cardiovascular disease. STE has a strong predictive value for cardiovascular function, therefore it would be a promising tool to add in the routine pregnancy clinical care. Speckle tracking echocardiography (STE) is a relative new technique especially in the pregnancy follow up, which permits offline calculation of myocardial velocities and deformation parameters. These parameters, including strain and strain rate, provide information about the fetal myocardial function. Apart from investigating if STE can be used for the prediction of FGR, we will also investigate the association between fetal exposure to air pollution and in utero cardiac remodeling. Indeed, it is known that inhalation of particulate matter (e.g. black carbon) during the pregnancy can reach the placenta and lead to alterations in the placenta's function including increases in oxidative stress markers. Early life exposure to black carbon has been associated with adverse cardiovascular health outcomes and reduction of fetal growth, especially in multiple gestation pregnancies.

In this project we will include 2 time points during the pregnancy, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. The fetal growth parameters will be collected at the same time points, to define the growth (differences) throughout gestation of both fetuses. A maternal blood sample will be taken at 20 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton or dichorionic twin pregnancy
  • Pregnant women 21 weeks ( ± 2 weeks) of gestation at the first visit
  • Women ≥ 18 years

排除标准

  • Women pregnant of multiples of higher order (≥3 siblings) Monochorionic twin pregnancy
  • Fetal arrhythmia
  • Known fetal congenital or genetic abnormalities
  • Any suspicion of congenital fetal anomalies that might influence fetal cardiac function
  • Pre-existing maternal hypertensive disease
  • Autoimmune disease including systemic lupus erythematosus
  • History of stillbirth
  • Diabetes mellitus (mother)

结局指标

主要结局

To compare the strain values (cardiac remodeling) between singletons and twin pregnancies

时间窗: Prenatal to 1-3 days after birth

to compare the changes in strain and strain rate between singletons and twin pregnancies

To assess the change in strain measured by speckle tracking echocardiography as a tool for early diagnosis of impaired fetal growth in multiple gestations

时间窗: Prenatal to 1-3 days after birth

to determine the change in fetal strain and strain rate in twin pregnancies in comparison with fetal growth

To determine the intra-pair differences in fetal growth and strain (cardiac remodeling) in multiple gestations.

时间窗: Prenatal to 1-3 days after birth

to compare changes in strain and strain rate with fetal growth within 1 twin pair

次要结局

  • To study the association between prenatal air pollution exposure and in utero cardiac remodeling(Prenatal to 1-3 days after birth)
  • To investigate the association between placenta functioning and in utero cardiac remodeling(Prenatal to 1-3 days after birth)
  • To explore in utero cardiac remodeling in association with neonatal cardiovascular health(Prenatal to 1-3 days after birth)
  • To investigate placenta functioning as a mediator between air pollution and cardiac remodeling(Prenatal to 1-3 days after birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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