Congenital Anomalies in Infants of Diabetic Mother

NCT05393167 | Unknown

• 1 other identifier: infants'congenital anomly
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to determine the pattern of congenital anomalies associated with maternal diabetes mellitus in newborns attending Assiut University children's Hospital.

Conditions

Congenital Abnormalities

Outcome Measures

Primary Outcomes (1)

• to determine the pattern of congenital anomalies associated with maternal diabetes mellitus in newborns

  Careful evaluation and early diagnosis of congenital anomalies in this high-risk group.

  baseline

Interventions

Echo_CT_MRI_US_x ray DEVICE

Examination: General and systemic examinations of the studied neonates. Investigation will be done to the neonates according to the clinical examination including imaging studies as X-rays, U/S, echocardiography, CT and MRI studies

Eligibility Criteria

• Age: 24 Days - 1 Year
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will include all births of diabetic mothers

You may qualify if:

• The study will include all births of diabetic mothers

You may not qualify if:

• Other risk factors of congenital anomalies, such as TORCH infections, teratogenic drugs or irradiation.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Nasri HZ, Houde Ng K, Westgate MN, Hunt AT, Holmes LB. Malformations among infants of mothers with insulin-dependent diabetes: Is there a recognizable pattern of abnormalities? Birth Defects Res. 2018 Jan;110(2):108-113. doi: 10.1002/bdr2.1155.

  PMID: 29377640 BACKGROUND

• Orbain MM, Johnson J, Nance A, Romeo AN, Silver MA, Martinez L, Leen-Mitchell M, Carey JC. Maternal diabetes-related malformations in Utah: A population study of birth prevalence 2001-2016. Birth Defects Res. 2021 Jan 15;113(2):152-160. doi: 10.1002/bdr2.1843. Epub 2020 Nov 23.

  PMID: 33226174 BACKGROUND

• Ognean L, Boanta O, Visa G, Grosu F, Sofariu C, Gafencu M, Matei C, Iurian S. HYDROCEPHALY, SCHIZENCEPHALY, SPONDYLOCOSTAL DYSPLASIA, AND HYPOPARATHYROIDISM IN AN INFANT OF A DIABETIC MOTHER. Acta Endocrinol (Buchar). 2017 Oct-Dec;13(4):494-501. doi: 10.4183/aeb.2017.494.

  PMID: 31149221 BACKGROUND

• Gabbay-Benziv R, Reece EA, Wang F, Yang P. Birth defects in pregestational diabetes: Defect range, glycemic threshold and pathogenesis. World J Diabetes. 2015 Apr 15;6(3):481-8. doi: 10.4239/wjd.v6.i3.481.

  PMID: 25897357 BACKGROUND

• al-Gazali LI, Dawodu AH, Sabarinathan K, Varghese M. The profile of major congenital abnormalities in the United Arab Emirates (UAE) population. J Med Genet. 1995 Jan;32(1):7-13. doi: 10.1136/jmg.32.1.7.

  PMID: 7897633 BACKGROUND

• Sawardekar KP. Profile of major congenital malformations at Nizwa Hospital, Oman: 10-year review. J Paediatr Child Health. 2005 Jul;41(7):323-30. doi: 10.1111/j.1440-1754.2005.00625.x.

  PMID: 16014135 BACKGROUND

• Walden RV, Taylor SC, Hansen NI, Poole WK, Stoll BJ, Abuelo D, Vohr BR; National Institute of Child Health and Human Development Neonatal Research Network. Major congenital anomalies place extremely low birth weight infants at higher risk for poor growth and developmental outcomes. Pediatrics. 2007 Dec;120(6):e1512-9. doi: 10.1542/peds.2007-0354. Epub 2007 Nov 5.

  PMID: 17984212 BACKGROUND

• Anyanwu LJC, Danborno B, Hamman WO. Birth prevalence of overt congenital anomalies in Kano Metropolis: overt congenital anomalies in the Kano. Uni J Pub Health. 2015;3(2):89-96.

  BACKGROUND

• Kingston HM. ABC of clinical genetics. 3rd ed. London: BMJ Books; 2002.

  BACKGROUND

• Ameen SK, Alalaf SK, Shabila NP. Pattern of congenital anomalies at birth and their correlations with maternal characteristics in the maternity teaching hospital, Erbil city, Iraq. BMC Pregnancy Childbirth. 2018 Dec 18;18(1):501. doi: 10.1186/s12884-018-2141-2.

  PMID: 30563491 BACKGROUND

• Aberg A, Westbom L, Kallen B. Congenital malformations among infants whose mothers had gestational diabetes or preexisting diabetes. Early Hum Dev. 2001 Mar;61(2):85-95. doi: 10.1016/s0378-3782(00)00125-0.

  PMID: 11223271 BACKGROUND

• 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.

  PMID: 16946226 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Marina Abd Elsabour Adly

CONTACT

01280617477; marinaabdelsabour@gmail.com

Hekmat Saad Farghaly

CONTACT

01091251040; Hekmah.othman@med.au.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share