Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06048562
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2023-09-16
Brief Title:
Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU at Assiut University Children Hospital During One Year
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate all full term infants of diabetic mother for the presence of hypertrophic cardiomyopathy who admitted in NICU at Assiut University Children Hospital and to follow up of these cases after 6 months for recovery
Detailed Description:
Diabetes is the most common endocrine disorder complicating pregnancy Incidence of both type-I and type-II diabetes is increasing throughout the world As the incidence of diabetes continues to rise and increasingly affects individuals of all ages including young adults and children women in child bearing age are at increased risk of diabetes during pregnancy 1
The type 1 diabetes around the time of conception produces marked risk of embryopathy neural tube defects cardiac defects and caudal regression syndrome as these mother have high glycosylated hemoglobin at the time of embryogenesis around 6-8 weeks of gestation rather than IDM that are born to type 2 diabetes mothers who have macrosomia and other milder problems The mothers who have been diagnosed as severe and unstable type1 diabetes in the later part of gestation have high chances of neonate being more affected with intrauterine growth restriction asphyxia and fetal death 2 and 3
Due to the teratogenic effect of maternal diabetes the reported incidence of congenital malformations among the newborns of diabetic mothers is five times greater than that of the general population 4
Cardiac malformations are one of the most common types of these malformations which occur in about 85 of cases that is about 10 times more than its incidence in normal population 08 5
Fetuses exposed to maternal hyperglycemia and hyperinsulinism are prone to develop hypertrophic cardiomyopathy It primarily affects the inter-ventricular septum but can extend to the myocardium in more severe cases Although the perinatal mortality rates associated with diabetes in pregnancy have declined considerably during the past eight decades and are now near those in the general population it is only through continuing vigilance that such advances can be maintained Both fetal and neonatal deaths occurred with increased frequency in diabetic pregnancies before the advent of modern management methods and fetal deaths nationwide continue to be significantly higher among diabetic than non-diabetic pregnancies 6
The most recent available data indicate that the relative risk of stillbirth in pregnancies complicated by type 1 diabetes compared to the general population is 29-43 folds and for type 2 diabetes 25-45 fold 7
The type 1 diabetes around the time of conception produces marked risk of embryopathy neural tube defects cardiac defects and caudal regression syndrome as these mother have high glycosylated hemoglobin at the time of embryogenesis around 6-8 weeks of gestation rather than IDM that are born to type 2 diabetes mothers who have macrosomia and other milder problems The mothers who have been diagnosed as severe and unstable type1 diabetes in the later part of gestation have high chances of neonate being more affected with intrauterine growth restriction asphyxia and fetal death 2 and 3
Due to the teratogenic effect of maternal diabetes the reported incidence of congenital malformations among the newborns of diabetic mothers is five times greater than that of the general population 4
Cardiac malformations are one of the most common types of these malformations which occur in about 85 of cases that is about 10 times more than its incidence in normal population 08 5
Fetuses exposed to maternal hyperglycemia and hyperinsulinism are prone to develop hypertrophic cardiomyopathy It primarily affects the inter-ventricular septum but can extend to the myocardium in more severe cases Although the perinatal mortality rates associated with diabetes in pregnancy have declined considerably during the past eight decades and are now near those in the general population it is only through continuing vigilance that such advances can be maintained Both fetal and neonatal deaths occurred with increased frequency in diabetic pregnancies before the advent of modern management methods and fetal deaths nationwide continue to be significantly higher among diabetic than non-diabetic pregnancies 6
The most recent available data indicate that the relative risk of stillbirth in pregnancies complicated by type 1 diabetes compared to the general population is 29-43 folds and for type 2 diabetes 25-45 fold 7
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None