Congenital Heart Defects

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06124443
Collaborator
(none)
60
17.9

Study Details

Study Description

Brief Summary

Describe the relationship between maternal diabetes and congenital heart defects in infants born to diabetic mothers referred to NICU unit & Outpatient clinics of Assiut University Childeren's hospital.We will compare between 2 groups. Cases will represent infants of diabetic mothers & Conteols will represent infants of non-diabetic mothers.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Congenital heart disease is defined as a gross structural abnormality of the heart or intra-thoracic great vessels that is actually or potentially of functional significance .The prevalence of CHD at birth has been relatively variable at 4.05 to 10.4 cases per 1000 live births in different surveys however,it is 5.0% in infants of diabetic mothers (IDMs).CHD is the most common congenital problem in children accounting for nearly 25% of all congenital malformations .CHDs are one of the significant causes of infant morbidity and mortality. Gestational diabetes mellitus (GDM) is the most common medical complication of pregnancy. It is associated with maternal and neonatal adverse outcomes. Maintaining adequate blood glucose levels in GDM reduces morbidity for both mother and baby. Pregnancy is associated with insulin resistance (IR) and hyperinsulinemia that may predispose some women to develop diabetes. Gestational diabetes has been defined as any degree of glucose intolerance with an onset, or first recognition during pregnancy. Diabetes during pregnancy could be a de novo that arises during pregnancy for the first time and could disappear or persist after delivery (gestational DM) or could start as pre-gestational, before the onset of pregnancy. The incidence of impaired glucose tolerance in pregnancy ranges between 3-10% and varies according to the average incidence of diabetes in the general Population. Specific CHDs that are more commonly seen in IDMs include ventricular septal defect (VSD), transposition of the great arteries (TGAs), and aortic stenosis (AS).Approximately one third of neonates with CHD require intervention in the first month of life . Clinical manifestation of CHD varies according to the type of lesion. Neonates with respiratory distress , cyanosis, feeding difficulties, and low cardiac output are common presentations of CHD . So diagnosis of CHD at the earliest possible time is very important as early referral and appropriate intervention in some of these cases are lifesaving.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Maternal Diabetes as a Risk Factor for Congenital Heart Defects in Infants of Diabetic Mothers.
    Anticipated Study Start Date :
    Dec 1, 2024
    Anticipated Primary Completion Date :
    Feb 28, 2026
    Anticipated Study Completion Date :
    May 31, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    Cases

    Infants & children of diabetic mothers

    Controls

    Infants & children of non-diabetic mothers

    Outcome Measures

    Primary Outcome Measures

    1. Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers. [Baseline]

      Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    The study will include infants of diabetic mothers and infants of non-diabetic mothers not previously screened for congenital heart defects.

    Exclusion Criteria:

    Other risk factors for congenital heart defects including congenital infections like TORCH infection, teratogenic drugs ( lithium or isotretinoin), , alcohol, or smoking.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Moustafa Adel Mohamed Ahmed, 71515,Assiut, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06124443
    Other Study ID Numbers:
    • Congenital heart defects
    First Posted:
    Nov 9, 2023
    Last Update Posted:
    Nov 9, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2023