Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU at Assiut University Children Hospital During One Year

Incidence of Hypertrophic Cardiomyopathy in Infants of Diabetic Mothers Attending in NICU

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Cardiomyopathy
• Intervention / Treatment: Diagnostic test: echocardiography

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].

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 17155
    • Ahmed Abdelkareem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• all infants of diabetic mothers were admitted at NICU

Exclusion Criteria:

• NO

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: idm; evaluation idm for cardiomyopathy	Diagnostic test: echocardiography; evaluation idm for cardiomyopathy by echo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
evaluate hypertrophic cardiomyopathty in IDM	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• [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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: September 16, 2023
• First Submitted That Met QC Criteria: September 16, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: hypertrophic cardiomyopathy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No