Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574386
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Pregnancy in GUCH Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pregnancy in GUCH Patients Maternal-Foetal-Neonatal Aspects at Mid Term
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PURE-HEART
Brief Summary:
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 newbornschildren 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
The main question it aims to answer is
-Does maternal congenital heart disease affects outcomes of newborn
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None