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

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06048562
• Other study ID #: hypertrophic cardiomyopathy
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: October 20, 2022

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Hours to 30 Days

Eligibility

Inclusion Criteria:

• all infants of diabetic mothers were admitted at NICU

Exclusion Criteria:

• NO

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Diagnostic Test:
• echocardiography
evaluation idm for cardiomyopathy by echo

Locations

Country	Name	City	State
Egypt	Ahmed Abdelkareem	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

[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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate hypertrophic cardiomyopathty in IDM		1 year