Infants of Diabetic Mothers in Neonatology Unit at Assiut University Children's Hospital

Not yet recruiting

• Conditions: Infant of Diabetic Mother

• Registration Number: NCT06111157
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Study First Submitted: 2023-10-14
• Study First Submitted QC: 2023-10-30
• Status Verified: 2023-11
• Study First Posted: 2023-11-01
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Study Start: 2024-03
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• The study will include all live births of diabetic mothers attending and admitted to Neonatal intensive Care Unit of Assiut University Children's Hospital .

Exclusion Criteria

• Babies born to non diabetic mothers .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine clinical spectrum of infants of diabetic mothers at neonatology unit of Assiut university children's hospital	Baseline	Mesure weight in kelograms
Determine clinical spectrum of infants of diabetic mothers	baseline	Mesure head circumference in centimeters