Congenital Anomalies in Infants of Diabetic Mother

Congenital Abnormalities Clinical Trial

Official title:

Pattern of Congenital Anomalies in Infants of Diabetic Mother .

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05393167
• Other study ID #: infants'congenital anomly
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: Marina Abd Elsabour Adly
• Phone: 01280617477
• Email: marinaabdelsabour[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Infants of diabetic mothers have been shown in several studies to have an increased frequency of malformations. In previous studies, an increased frequency of several specific malformations has been noted, including anencephaly, bilateral renal agenesis, and double outlet right ventricle. Surveillance, used to identify all malformed infants in a consecutive sample of births, can identify a distinctive pattern of malformations among the affected infants.(1) Maternal pregestational diabetes mellitus is associated with an increased risk for congenital malformations of about2-4 times the background risk.(2) Perinatal outcome of the infant of the diabetic mother (IDM) depends on the onset, duration, and severity of maternal diabetes and is worse for IDM born from mothers with pre-existent insulin-dependent diabetes.(3) that glycemic control is associated with a reduced risk of congenital anomalies. However, the recommended threshold of HgA1c for pregestational diabetic women planning pregnancy is still not known.(4) Congenital anomalies are broadly classified into either single-system or multiple-system malformations. The first type affects a single organ system or body part,(5,6,7) and the second affects more than one organ system or body part. Major congenital anomalies are defined as those that, if uncorrected, could result in considerable impairment of the normal body functions or even reducing the life expectancy. Minor congenital anomalies include the anomalies that cause no disability or have no significant physical or functional effects and can be regarded as normal variants.(5,8,9) In another study conducted in Egypt on live-born babies, the incidence of minor congenital anomalies among infants of diabetic mothers was 18%, while the incidence was 11% for the major congenital anomalies, the later was 4.6 times higher than in the general population.(10) The pathophysiology of maternal diabetes induced birth defects is complex, however, clearly relates to maternal glucose levels. The mechanism is not entirely understood, but animal studies have shown it to be associated with decreased cell proliferation and increased cell apoptosis due to high oxidative stress, the second major change is altered gene expression causing deviation from the normal developmental process.(11) However, most congenital defects associated with diabetes occur in the cardiovascular, central nervous and musculoskeletal systems. Although hyperglycemia is a common mechanism for teratogenicity, differences in disease characteristics, such as age of onset, ethnicity, obesity and duration of disease, may affect the disease impact on the perinatal outcome and the rate of congenital anomalies.(11,12)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: October 2023
• Gender: All
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• The study will include all births of diabetic mothers

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Congenital Abnormalities

Intervention

Device:
• Echo_CT_MRI_US_x ray
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (12)

Aberg A, Westbom L, Källén B. Congenital malformations among infants whose mothers had gestational diabetes or preexisting diabetes. Early Hum Dev. 2001 Mar;61(2):85-95. — View Citation

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. — View Citation

Ameen, S.K., Alalaf, S.K. & Shabila, N.P. Pattern of congenital anomalies at birth and their correlations with maternal characteristics in the maternity teaching hospital, Erbil city, Iraq. BMC Pregnancy Childbirth.(2018),18, 501 . https://doi.org/10.1186/s12884-018-2141-2

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.

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. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Sawardekar KP. Profile of major congenital malformations at Nizwa Hospital, Oman: 10-year review. J Paediatr Child Health. 2005 Jul;41(7):323-30. — View Citation

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. Epub 2007 Nov 5. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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