Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU at Assiut University Children Hospital During One Year
Primary Purpose
Hypertrophic Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
echocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertrophic Cardiomyopathy
Eligibility Criteria
Inclusion Criteria: all infants of diabetic mothers were admitted at NICU Exclusion Criteria: NO
Sites / Locations
- Ahmed Abdelkareem
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
idm
Arm Description
evaluation idm for cardiomyopathy
Outcomes
Primary Outcome Measures
evaluate hypertrophic cardiomyopathty in IDM
Secondary Outcome Measures
Full Information
NCT ID
NCT06048562
First Posted
September 16, 2023
Last Updated
September 16, 2023
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT06048562
Brief Title
Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU at Assiut University Children Hospital During One Year
Official Title
Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
October 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 8.5% of cases that is about 10 times more than its incidence in normal population (0.8%) [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 2.9-4.3 folds, and for type 2 diabetes 2.5-4.5 fold [7].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
idm
Arm Type
Experimental
Arm Description
evaluation idm for cardiomyopathy
Intervention Type
Diagnostic Test
Intervention Name(s)
echocardiography
Intervention Description
evaluation idm for cardiomyopathy by echo
Primary Outcome Measure Information:
Title
evaluate hypertrophic cardiomyopathty in IDM
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Hours
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all infants of diabetic mothers were admitted at NICU
Exclusion Criteria:
NO
Facility Information:
Facility Name
Ahmed Abdelkareem
City
Assiut
ZIP/Postal Code
17155
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16946226
Citation
Yang J, Cummings EA, O'connell C, Jangaard K. Fetal and neonatal outcomes of diabetic pregnancies. Obstet Gynecol. 2006 Sep;108(3 Pt 1):644-50. doi: 10.1097/01.AOG.0000231688.08263.47.
Results Reference
background
Citation
[3] Correa A, Gilboa SM, Besser LM, Botto LD, Moore CA, Hobbs CA, etal, Diabetes mellitus and birth defects. Obstetric Anesthesia Digest. 2009 Mar 1;29(1):40-1.
Results Reference
background
PubMed Identifier
17572266
Citation
Hunt KJ, Schuller KL. The increasing prevalence of diabetes in pregnancy. Obstet Gynecol Clin North Am. 2007 Jun;34(2):173-99, vii. doi: 10.1016/j.ogc.2007.03.002.
Results Reference
result
Learn more about this trial
Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU at Assiut University Children Hospital During One Year
We'll reach out to this number within 24 hrs