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

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Gestational Diabetes
• Intervention / Treatment: Diagnostic test: Hearing screening tests

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 Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Turkey
  • Altindag
    • Ankara, Altindag, Turkey, 06230
      • Ankara Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women with gestational diabetes and women without diabetic pregnancy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children of GDM parents; Children of mothers who have gestational diabetes mellitus	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.
Children of non-diabetic parents; Children of mothers without diabetes	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Hearing loss	Rate of newborns who failed hearing screening tests	One year

Collaborators and Investigators

• Sponsor: Ankara Training and Research Hospital
• Investigators: Principal Investigator: Esra Gulen Yildiz, Ankara Training and Resarch Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: April 10, 2021
• First Submitted That Met QC Criteria: April 10, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Newborns; Hearing loss; Gestational diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Mellitus; Otorhinolaryngologic Diseases; Ear Diseases; Pregnancy Complications; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Diabetes, Gestational
• Other Study ID Numbers: CGDMP2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No