Pregnancy in GUCH Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Neurodevelopmental assessment.
- Кому может быть актуально
- Состояния в реестре: Congenital Heart Disease, Pregnancy Related, Infant Development, IUGR. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Pregnancy in GUCH Patients: Maternal-Foetal-Neonatal Aspects at Mid Term
Обзор
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?
Подробное описание
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
Вмешательства
- Диагностический тест Neurodevelopmental assessment
Neurodevelopmental assessment
Первичные конечные точки
- Neonatal outcomes in terms of weight and appropriate intrauterine development [Срок оценки: Assessment in the first, second and third trimester of pregnancy]
Вторичные конечные точки (12)
- Physical examination of the mother (BMI) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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): [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.]
- Assessment of foetal oxygenation [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.]
- Physical examination in newborns [Срок оценки: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth]
Критерии участия
Критерии включения
- 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 + 0.
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Италия · 1 центр
- Fondazione universitaria policlinico Agostino Gemelli — Roma
Идентификаторы
NCT: NCT06574386 · 6487