跳至主要内容
临床试验/NCT07092644
NCT07092644招募中不适用

Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年11月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
108
试验地点
1
主要终点
Maternal hemodynamic parametrics changes (Cardiac Output, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery

研究概览

简要总结

The goal of this study is to describe the maternal hemodynamic parameters detected by UltraSonic Cardiac Output Monitor (USCOM®) in women carrying a fetus with a congenital heart disease (CHD) and to possibly describe an association between those parameters and the presence of a fetal cardiac anomaly.

It will also learn about:

  • the number of cases of preeclampsia in our population of women carrying fetuses with CHD
  • the relationship between maternal hemodynamic profile and maternal and perinatal outcome
  • the associations between maternal hemodynamic parameters and the specific heart defect subtype
  • the relationship between maternal hemodynamic parameters and fetal cardiac parameters in our population.

The haemodynamic evaluation will be performed at the time of diagnosis of CHD and then every two weeks until delivery. A further evaluation will be performed immediately after delivery (within 72 hours).

详细描述

The following maternal hemodynamic indices will be evaluated: heart rate (HR) (beats per min; bpm), mean arterial pressure (mmHg), stroke volume (mL), cardiac output (CO) (L/min), systemic vascular resistance (dynes/s/cm5). Data on the demographic and pregnancy characteristics of participants, hemodynamic and ultrasound investigations, perinatal and delivery features will be also collected. In particular, the following variables will be included in the study: type of congenital heart defect, gestational age at diagnosis, fetal weight (EFW) and fetal weight centile at diagnosis of CHD and at the last scan before delivery, mean uterine arteries pulsatility index (UtA-PI), fetal umbilical artery (UA-PI) and middle cerebral artery pulsatility index (MCA-PI) at diagnosis and at the last scan before delivery, maternal age, height, pre-pregnancy weight and gestational weight gain, systolic and diastolic blood pressure values (maximum and minimum values), presence of proteinuria, biochemical maternal assessment (maximun and miminum values of creatinine and uric acid level, platelet count, liver enzyme level), incidence of hypertensive disorders of pregnancy, antihypertensive drug administration (type and dosage) including magnesium sulfate, antenatal steroid administration, mode of delivery and indications, gestational age at delivery, birthweight and birthweight centile, need of respiratory or cardiac support, neonatal intensive care unit admission and number of days, major neonatal complications, maternal morbidities (HELLP, eclampsia, intravascular disseminate coagulation, post-partum hemorrhage), and mortality. The following definitions of hypertensive disorders will be used, according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) 2018 criteria (14): chronic hypertension (CH) will be defined as hypertension (≥140/90mmHg) that predates pregnancy or is present prior to 20 weeks' gestation; gestational hypertension was defined as de-novo hypertension (≥ 140/90 mmHg) after 20 weeks' gestation; and preeclampsia (PE) will be defined as de-novo hypertension (≥ 140/90 mmHg) after 20 weeks' gestation with coexisting proteinuria, other maternal organ dysfunction or fetal growth restriction; preeclampsia superimposed to chronic hypertension (PE-CH).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Informed consent accepted
  • •Maternal Age ≥ 18 years
  • •Singleton pregnancy with a viable fetus at >20 weeks of gestation, with a diagnosis of congenital heart disease detected on antenatal ultrasound assessment and postnatally confirmed

排除标准

  • •Multiple pregnancy
  • •Pregnancy complicated by aneuploidy, genetic syndrome, or major structural fetal abnormality
  • •Maternal congenital heart disease (GUCH)
  • •Maternal known cardiac disease

研究组 & 干预措施

Hemodynamic evaluation in pregnant women carring a fetus with a congenital heart desease

Other

Hemodynamic indices will be obtained using the USCOM® system. Women will undergo a hemodynamic investigation at the time of first diagnosis of congenital heart disease during pregnancy or at the first assessment in Fondazione Policlinico A. Gemelli during pregnancy and then every two weeks until delivery. An additional hemodynamics evaluation will be performed in the post-partum period (in the 72 hours immediately after delivery). All hemodynamic assessment will be performed under standardized conditions.

干预措施: UltraSonic Cardiac Output Monitor (USCOM®) (Device)

结局指标

主要结局

Maternal hemodynamic parametrics changes (Cardiac Output, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery

时间窗: 36 months

Hemodynamic indices will be obtained using the USCOM® system. Women will undergo a hemodynamic investigation at the time of first diagnosis of congenital heart disease during pregnancy or at the first assessment in Fondazione Policlinico A. Gemelli during pregnancy and then every two weeks until delivery. An additional hemodynamics evaluation will be performed in the post-partum period (in the 72 hours immediately after delivery). All hemodynamic assessment will be performed under standardized conditions. Heart rate (HR) and stroke volume will be combined to report cardiac output (CO) in L/min.

Maternal hemodynamic parametrics changes (Systemic vascular resistance, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery

时间窗: 36 months

Hemodynamic indices will be obtained using the USCOM® system. Women will undergo a hemodynamic investigation at the time of first diagnosis of congenital heart disease during pregnancy or at the first assessment in Fondazione Policlinico A. Gemelli during pregnancy and then every two weeks until delivery. An additional hemodynamics evaluation will be performed in the post-partum period (in the 72 hours immediately after delivery). All hemodynamic assessment will be performed under standardized conditions. Systemic vascular resistance (dynes/s/cm5) will be evaluated.

次要结局

  • Correlation between maternal hemodynamic profile and perinatal outcome (birthweight)(36 months)
  • Correlation between maternal hemodynamic profile and perinatal outcome (major neonatal complications)(36 months)
  • Correlation between maternal hemodynamic profile and perinatal outcome (birthweight centile)(36 months)
  • Correlation between maternal hemodynamic profile (Cardiac Output) and perinatal outcome(36 months)
  • Correlation between maternal hemodynamic profile (Systemic vascular resistance) and perinatal outcome(36 months)
  • Correlation between maternal hemodynamic profile and perinatal outcome (gestational age at delivery)(36 months)
  • Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific heart defect type(36 months)
  • Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific fetal heart parameters(36 months)
  • Prevalence of cases of preeclampsia in our population of pregnancies complicated by congenital heart disease(36 months)
  • Correlation between maternal hemodynamic profile and perinatal outcome (neonatal intensive care unit admission)(36 months)
  • Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific heart defect type(36 months)
  • Correlation between maternal hemodynamic profile and perinatal outcome (need of respiratory or cardiac support)(36 months)
  • Correlation between maternal hemodynamic profile and perinatal outcome (number of days in neonatal intensive care unit)(36 months)
  • Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific fetal heart parameters(36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salvi Silvia

Medical Doctor Specialised in Obstetrics and Gyanecology

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

Loading locations...

相似试验