- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06124443
Congenital Heart Defects
November 5, 2023 updated by: Moustafa Adel Mohamed Ahmed, Assiut University
Maternal Diabetes as a Risk Factor for Congenital Heart Defects in Infants of Diabetic Mothers.
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Moustafa Adel Mohamed Ahmed
- Phone Number: +201123248863
- Email: dr.mostafaaboelsoud2020@gmail.com
Study Contact Backup
- Name: Mohamed Gamil Mohamed Aboelela, Dr
- Phone Number: +201024741834
- Email: mohamedgamilmohamed@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Neonates and children of diabetic and non-diabetic mothers
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Cases
Infants & children of diabetic mothers
|
Controls
Infants & children of non-diabetic mothers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers.
Time Frame: Baseline
|
Assesment of prevalence of congenital heart defects among infants of diabetic mother compared to that in infants of non-diabetic mothers.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. National Diabetes Data Group. Diabetes. 1979 Dec;28(12):1039-57. doi: 10.2337/diab.28.12.1039. No abstract available.
- Al-Biltagi M, Tolba OA, Rowisha MA, Mahfouz Ael-S, Elewa MA. Speckle tracking and myocardial tissue imaging in infant of diabetic mother with gestational and pregestational diabetes. Pediatr Cardiol. 2015 Feb;36(2):445-53. doi: 10.1007/s00246-014-1033-0. Epub 2014 Oct 7.
- Aburawi EH. The burden of congenital heart disease in libya. Libyan J Med. 2006 Sep 8;1(2):120-2. doi: 10.4176/060902. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2024
Primary Completion (Estimated)
February 28, 2026
Study Completion (Estimated)
May 31, 2026
Study Registration Dates
First Submitted
November 5, 2023
First Submitted That Met QC Criteria
November 5, 2023
First Posted (Estimated)
November 9, 2023
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 5, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Congenital heart defects
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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