NCT06574386尚未招募不适用
Pregnancy in GUCH Patients: Maternal-Foetal-Neonatal Aspects at Mid Term
Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Neonatal outcomes in terms of weight and appropriate intrauterine development
研究概览
简要总结
This study aims to investigate the impact of congenital heart diseases on maternal and foetal-neonatal health, the effect of pregnancy on maternal cardiac health, and the outcome of newborns/children born from Grown-Up Congenital Heart (GUCH) mothers with follow-up at one year, extendable to two.
The main question it aims to answer is:
-Does maternal congenital heart disease affects outcomes of newborn?
详细描述
After being informed about the study and potential risks all patients giving written informed consent will undergo:
- Cardiological and obstetric evaluation in the first trimester of pregnancy;
- Cardiological and obstetric revaluation in the second trimester of pregnancy;
- Cardiological and obstetric revaluation in the third trimester of pregnancy;
- Cardiac and general neonatal evaluation at birth;
- 2-year follow-up: maternal and neonatal cardiology evaluation, childhood neurodevelopment evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Congenital heart disease in natural history or undergoing corrective and/or palliative cardiothoracic surgery.
- •Chronological age > 18 years.
- •Single pregnancy progressing normally at a gestational age of 14 weeks +
- •Correct pregnancy dating based on CRL as per ISUOG guidelines. (26)
- •Normal results of non-invasive screening tests for foetal aneuploidies.
- •Normal first-trimester ultrasound examination.
- •Informed consent of the woman.
排除标准
- •Maternal chromosomal abnormalities.
- •Maternal syndromic conditions.
- •Spontaneous abortion.
- •Vanishing Twin.
- •High risk for chromosomal abnormalities on screening tests performed in the 1st Trimester (Combined Test/NIPT) or Major foetal structural anomalies identified during first-trimester ultrasound evaluation.
结局指标
主要结局
Neonatal outcomes in terms of weight and appropriate intrauterine development
时间窗: Assessment in the first, second and third trimester of pregnancy
Observation of neonatal outcome in terms of incidence of foetal growth restriction (FGR), defined as deviation from genetic potential with neonates classified as small for gestational age (SGA) or adequate for gestational age (AGA).
次要结局
- Physical examination of the mother (BMI)(Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth)
- Systolic and diastolic blood pressure of the mother during pregnancy(Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth)
- NYHA class progression during pregnancy (NYHA functional class)(Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth)
- Cardiologic assessment of the mother (Electrocardiogram):(Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth)
- Cardiologic assesment of the mother (Echocardiography)(Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth)
- Cardiologic assesment of the mother (24-hour Holter ECG)(Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth)
- Cardiologic assesment of the mother (24-hour Holter BP)(Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth)
- Assessment of foetal growth and weight (Subcutaneous Adipose Thickness SCAT)(Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.)
- Assessment of foetal oxygenation(Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.)
- Numbers of obstetric and maternal complications(Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.)
- Cardiological evaluation of the fetus(Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.)
- Physical examination in newborns(Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth)
- Newborn's health and vital signs(At birth)
- Fetal metabolic condition(At birth)
- Cardiologic assessment in newborns (Electrocardiogram)(Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.)
- Cardiologic assesment in newborns (Echocardiography)(Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.)
- Neurological examination in newborns(Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.)
- Neurodevelopmental assessment in newborns (Hammersmith Infant Neurological Examination)(Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.)
- Physical growth in newborns (BMI)(Performed at birth, three months, and twelve months of age.)
- Physical growth in newborns (head circumference in Cm)(Performed at birth, three months, and twelve months of age.)
- Respiratory function in newborns(Performed at birth, three months, and twelve months of age.)
研究者
研究点 (2)
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