Infants of Diabetic Mothers in Neonatology Unit at Assiut University Children's Hospital
NCT ID: NCT06111157
Last Updated: 2023-11-09
Study Results
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Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2024-03-31
2025-04-30
Brief Summary
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Detailed Description
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Diabetes during pregnancy has been associated with several maternal and fetal problems .
Diabetes during pregnancy include gestational diabetes which is defined as carbohydrate intolerance of varying degrees with hyperglycemia starting during pregnancy ,generally develops in the second half of pregnancy .
While pregestational diabetes is the condition in which a woman with diabetes ( type 1 or commonly type 2 ) before the onset of pregnancy .
Both gestational and pregestational diabetes are associated with increased rates of adverse maternal and neonatal outcomes . Adverse outcomes are more common with pregestational diabetes compared to gestational diabetes mellitus ; although , conflicting results have been reported .
Inspite the huge progress in the treatment of diabetes mellitus , Investigators are still in the situation that both gestational and pregestational diabetes impose an additional risk to the embryo , fetus , and course of pregnancy Pregestational diabetes mellitus increases the rate of congenital malformations , especially cardiac such as Patent foramen ovale , hypertrophic cardiomyopathy , Atrial septal defect , ventricular septal defect .
Fetal macrosomia is a common adverse effect on the infant outcomes . It increases the risk of shoulder dystocia , clavicle fractures , brachial plexus injury , which increase the rate of admission to the neonatal intensive care unit .
This infant may experience asphyxia , respiratory distress , hypoglycemia or hyperglycemia , hyperinsulinemia , hypocalcemia , hypomagnesemia , hyperbilirubinemia , polycythemia and anemia .
Caudal regression syndrome , anencephaly , microcephaly , hydrocephalus , spina bifida are also complications of diabetes mellitus in pregnancy .
Both gestational and pregestational diabetes may also cause various motor and behaviouralneurodevelopmental problems including an increased incidence of attention deficit hyperactivity disorder and autism spectrum disorder .
It has been found that there is increased rate of obesity , impaired glucose intolerance or diabetes mellitus in the childhood and adolescence .
Mechanisms of diabetic induced damage in pregnancyare related to maternal and fetal hyperglycemia ,enhanced oxidation status , epigenetic changes and other less defined pathogenic mechanisms .
Uncontrolled diabetes has profound effects on embryogenesis , organogenesis , and fetal and neonatal growth .
The severity of complications is higher with earlier onset of gestational diabetes mellitus and inversely correlated with the degree of glycemic control .
Early initiation of gestational diabetes mellitus might even cause some increase in the rate of congenital malformations .
Tight glycemic control prior to conception and during pregnancy can prevent an excess rate of congenital malformations ,macrosomia , birth trauma and neonatal respiratory distress syndrome .
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Dina Nasser Mahrous Danial
Principle investigator
Principal Investigators
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Safwat Mohamed Abdel-aziz, Assistant professor
Role: STUDY_DIRECTOR
Assiut University
Shimaa Kamal Mohamed, Lecturer
Role: STUDY_DIRECTOR
Assiut University
Central Contacts
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References
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Singh S, Yadav M. Gestational Diabetes Mellitus among Pregnant Women Delivering in a Tertiary Care Hospital: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2022 Mar 11;60(247):229-233. doi: 10.31729/jnma.7304.
Ornoy A, Becker M, Weinstein-Fudim L, Ergaz Z. Diabetes during Pregnancy: A Maternal Disease Complicating the Course of Pregnancy with Long-Term Deleterious Effects on the Offspring. A Clinical Review. Int J Mol Sci. 2021 Mar 15;22(6):2965. doi: 10.3390/ijms22062965.
Malaza N, Masete M, Adam S, Dias S, Nyawo T, Pheiffer C. A Systematic Review to Compare Adverse Pregnancy Outcomes in Women with Pregestational Diabetes and Gestational Diabetes. Int J Environ Res Public Health. 2022 Aug 31;19(17):10846. doi: 10.3390/ijerph191710846.
Akbariasbagh P, Shariat M, Akbariasbagh N, Ebrahim B. Cardiovascular Malformations in Infants of Diabetic Mothers: A Retrospective Case-Control Study. Acta Med Iran. 2017 Feb;55(2):103-108.
Kc K, Shakya S, Zhang H. Gestational diabetes mellitus and macrosomia: a literature review. Ann Nutr Metab. 2015;66 Suppl 2:14-20. doi: 10.1159/000371628. Epub 2015 Jun 2.
Weintrob N, Karp M, Hod M. Short- and long-range complications in offspring of diabetic mothers. J Diabetes Complications. 1996 Sep-Oct;10(5):294-301. doi: 10.1016/1056-8727(95)00080-1.
[7] J. L. Kitzmiller, A. Ferrara, T. Peng, M. A. Cissell, and C. Kim, "Chapter 5: Preexisting Diabetes and Pregnancy."
Other Identifiers
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Infants of diabetic mothers
Identifier Type: -
Identifier Source: org_study_id
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