Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic Mothers

Completed

• Conditions: Hearing Loss; Gestational Diabetes
• Interventions: Diagnostic Test: Hearing screening tests

• Registration Number: NCT04845412
• Lead Sponsor: Ankara Training and Research Hospital

Brief Summary

In this study, the investigators have aimed to investigate whether GDM is a risk factor for hearing impairment in newborns. To the investigators knowledge, this study is the first prospective, controlled study on this subject.

Detailed Description

Gestational diabetes mellitus (GDM) is an increasingly frequent condition in the world causing significant morbidity and mortality. GDM is a metabolic disease that develops in pregnancy, and may result in complications in the pregnant women, similar to other patients with diabetes. The prevalence of GDM varies in relation with the population and the diagnostic criteria. Diabetes affects 6-9% of pregnant women; 99% of the cases have GDM, and diabetes is diagnosed before pregnancy in the remaining 1% \[(pre-gestational diabetes mellitus (pre-GDM)\]. Hearing loss is one of the most common birth defect in newborns. The incidence of congenital hearing impairment is 2-3 per 1000 births. Early diagnosis and treatment is very important for the development of auditory pathways and protection of cognitive functions. Therefore, newborn hearing screening programs have been in use in a number of countries. Transient evoked otoacoustic emissions (TEOAE) and auditory brainstem response (ABR) have been identified as basic convenient and applicable tools for neonatal screening of hearing.

Suboptimal glycemic control during pregnancy has adverse fetal effects. Congenital malformations, preterm birth and neonatal respiratory distress in the newborn are more common, at varying rates, pre-GDM and GDM. Compared to the normal population, the risk of congenital malformations is 1.9-10 fold higher in presence of pre-GDM, and 1.1-1.3 fold higher in presence of GDM. Despite our awareness on these important complications, the effect of intrauterine hyperglycemia on hearing of the newborn has not yet been studied in detail. Diabetes mellitus (DM) often causes hearing impairment, however little is known whether GDM is an antenatal risk factor for cochlear damage and hearing loss.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-04-10
• Last Update Submitted: 2021-04-14
• Study First Posted: 2021-04-15
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

• Women with gestational diabetes
• Women without diabetic pregnancy

Exclusion Criteria

• Admitted to the neonatal intensive care unit for more than five days
• Perinatal asphyxia
• Craniofacial abnormalities
• İntrauterine infections
• Hyperbilirubinemia requiring exchange transfusion
• Very low birth weight (<1500 g)
• Gestational hypertension
• Preeclampsia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children of non-diabetic parents	Hearing screening tests	Children of mothers without diabetes
Children of GDM parents	Hearing screening tests	Children of mothers who have gestational diabetes mellitus

Primary Outcome Measures

Name	Time	Method
Rate of Hearing loss	One year	Rate of newborns who failed hearing screening tests

Trial Locations

Locations (1)

Ankara Training and Research Hospital; 🇹🇷 Ankara, Altindag, Turkey