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

Hearing Loss Clinical Trial

Official title:

Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic and Non-diabetic Mothers: a Prospective, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845412
• Other study ID #: CGDMP2020
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2021
• Source: Ankara Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

• Intrauterine infections

• Hyperbilirubinemia requiring exchange transfusion

• Very low birth weight (<1500 g)

• Gestational hypertension

• Preeclampsia

Related Conditions & MeSH terms

• Deafness
• Diabetes, Gestational
• Gestational Diabetes
• Hearing Loss

Intervention

Diagnostic Test:
• Hearing screening tests
Our study was conducted in accordance with the National Hearing Screening Test Protocol. The newborns had transient evoked otoacoustic emissions (TEOAE) with "click" stimulus as a hearing screening test in the first three days after birth, using Otometrics Madsen Accuscreen S/N: 36484 (USA) device.

Locations

Country	Name	City	State
Turkey	Ankara Training and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Hearing loss	Rate of newborns who failed hearing screening tests	One year