Infants of Diabetic Mothers in Neonatology Unit at Assiut University Children's Hospital

NCT ID: NCT06111157

Last Updated: 2023-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-04-30

Brief Summary

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Determine spectrum of clinical presentations and complications associated with maternal diabetes mellitus in their newborns attending and admitted to Neonatal Intensive Care Unit of Assiut University Children's Hospital.

Detailed Description

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The global incidence of diabetes mellitus including diabetes of pregnant women is on the rise .

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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Infant of Diabetic Mother

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* The study will include all live births of diabetic mothers attending and admitted to Neonatal intensive Care Unit of Assiut University Children's Hospital .

Exclusion Criteria

* Babies born to non diabetic mothers .
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Dina Nasser Mahrous Danial

Principle investigator

Responsibility Role PRINCIPAL_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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Dina Nasser Mahrous, Bachelor's

Role: CONTACT

01286601551

Nafisa Refat Hassan, Professor

Role: CONTACT

01003472082

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.

Reference Type BACKGROUND
PMID: 35633259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33803995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36078559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28282706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26045324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8887019 (View on PubMed)

[7] J. L. Kitzmiller, A. Ferrara, T. Peng, M. A. Cissell, and C. Kim, "Chapter 5: Preexisting Diabetes and Pregnancy."

Reference Type BACKGROUND

Other Identifiers

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Infants of diabetic mothers

Identifier Type: -

Identifier Source: org_study_id

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