Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 8:11 AM
Study NCT ID:
NCT06111157
Status:
UNKNOWN
Last Update Posted:
2023-11-09
First Post:
2023-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infants of Diabetic Mothers in Neonatology Unit at Assiut University Children's Hospital
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Clinical Spectrum of Infants of Diabetic Mothers , in Neonatal Intensive Care Unit of Assiut University Children's Hospital
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
NOT_YET_RECRUITING
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:
Determine spectrum of clinical presentations and complications associated with maternal diabetes mellitus in their newborns attending and admitted to Neonatal Intensive Care Unit of Assiut University Children's Hospital.
Detailed Description:
The global incidence of diabetes mellitus including diabetes of pregnant women is on the rise .
Diabetes during pregnancy has been associated with several maternal and fetal problems .
Diabetes during pregnancy include gestational diabetes which is defined as carbohydrate intolerance of varying degrees with hyperglycemia starting during pregnancy ,generally develops in the second half of pregnancy .
While pregestational diabetes is the condition in which a woman with diabetes ( type 1 or commonly type 2 ) before the onset of pregnancy .
Both gestational and pregestational diabetes are associated with increased rates of adverse maternal and neonatal outcomes . Adverse outcomes are more common with pregestational diabetes compared to gestational diabetes mellitus ; although , conflicting results have been reported .
Inspite the huge progress in the treatment of diabetes mellitus , Investigators are still in the situation that both gestational and pregestational diabetes impose an additional risk to the embryo , fetus , and course of pregnancy Pregestational diabetes mellitus increases the rate of congenital malformations , especially cardiac such as Patent foramen ovale , hypertrophic cardiomyopathy , Atrial septal defect , ventricular septal defect .
Fetal macrosomia is a common adverse effect on the infant outcomes . It increases the risk of shoulder dystocia , clavicle fractures , brachial plexus injury , which increase the rate of admission to the neonatal intensive care unit .
This infant may experience asphyxia , respiratory distress , hypoglycemia or hyperglycemia , hyperinsulinemia , hypocalcemia , hypomagnesemia , hyperbilirubinemia , polycythemia and anemia .
Caudal regression syndrome , anencephaly , microcephaly , hydrocephalus , spina bifida are also complications of diabetes mellitus in pregnancy .
Both gestational and pregestational diabetes may also cause various motor and behaviouralneurodevelopmental problems including an increased incidence of attention deficit hyperactivity disorder and autism spectrum disorder .
It has been found that there is increased rate of obesity , impaired glucose intolerance or diabetes mellitus in the childhood and adolescence .
Mechanisms of diabetic induced damage in pregnancyare related to maternal and fetal hyperglycemia ,enhanced oxidation status , epigenetic changes and other less defined pathogenic mechanisms .
Uncontrolled diabetes has profound effects on embryogenesis , organogenesis , and fetal and neonatal growth .
The severity of complications is higher with earlier onset of gestational diabetes mellitus and inversely correlated with the degree of glycemic control .
Early initiation of gestational diabetes mellitus might even cause some increase in the rate of congenital malformations .
Tight glycemic control prior to conception and during pregnancy can prevent an excess rate of congenital malformations ,macrosomia , birth trauma and neonatal respiratory distress syndrome .
Diabetes during pregnancy has been associated with several maternal and fetal problems .
Diabetes during pregnancy include gestational diabetes which is defined as carbohydrate intolerance of varying degrees with hyperglycemia starting during pregnancy ,generally develops in the second half of pregnancy .
While pregestational diabetes is the condition in which a woman with diabetes ( type 1 or commonly type 2 ) before the onset of pregnancy .
Both gestational and pregestational diabetes are associated with increased rates of adverse maternal and neonatal outcomes . Adverse outcomes are more common with pregestational diabetes compared to gestational diabetes mellitus ; although , conflicting results have been reported .
Inspite the huge progress in the treatment of diabetes mellitus , Investigators are still in the situation that both gestational and pregestational diabetes impose an additional risk to the embryo , fetus , and course of pregnancy Pregestational diabetes mellitus increases the rate of congenital malformations , especially cardiac such as Patent foramen ovale , hypertrophic cardiomyopathy , Atrial septal defect , ventricular septal defect .
Fetal macrosomia is a common adverse effect on the infant outcomes . It increases the risk of shoulder dystocia , clavicle fractures , brachial plexus injury , which increase the rate of admission to the neonatal intensive care unit .
This infant may experience asphyxia , respiratory distress , hypoglycemia or hyperglycemia , hyperinsulinemia , hypocalcemia , hypomagnesemia , hyperbilirubinemia , polycythemia and anemia .
Caudal regression syndrome , anencephaly , microcephaly , hydrocephalus , spina bifida are also complications of diabetes mellitus in pregnancy .
Both gestational and pregestational diabetes may also cause various motor and behaviouralneurodevelopmental problems including an increased incidence of attention deficit hyperactivity disorder and autism spectrum disorder .
It has been found that there is increased rate of obesity , impaired glucose intolerance or diabetes mellitus in the childhood and adolescence .
Mechanisms of diabetic induced damage in pregnancyare related to maternal and fetal hyperglycemia ,enhanced oxidation status , epigenetic changes and other less defined pathogenic mechanisms .
Uncontrolled diabetes has profound effects on embryogenesis , organogenesis , and fetal and neonatal growth .
The severity of complications is higher with earlier onset of gestational diabetes mellitus and inversely correlated with the degree of glycemic control .
Early initiation of gestational diabetes mellitus might even cause some increase in the rate of congenital malformations .
Tight glycemic control prior to conception and during pregnancy can prevent an excess rate of congenital malformations ,macrosomia , birth trauma and neonatal respiratory distress syndrome .
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?: