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

NCT04845412 | Completed

• 1 other identifier: CGDMP2020
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Hearing Loss

Keywords

Gestational diabetes; Hearing loss; Newborns

Outcome Measures

Primary Outcomes (1)

• Rate of Hearing loss

  Rate of newborns who failed hearing screening tests

  One year

Study Arms (2)

Children of GDM parents

Children of mothers who have gestational diabetes mellitus

Diagnostic Test: Hearing screening tests

Children of non-diabetic parents

Children of mothers without diabetes

Diagnostic Test: Hearing screening tests

Interventions

Hearing screening tests DIAGNOSTIC_TEST

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 GDM parents; Children of non-diabetic parents

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women with gestational diabetes Women without diabetic pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women with gestational diabetes and women without diabetic pregnancy

You may qualify if:

• Women with gestational diabetes
• Women without diabetic pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational; Hearing Loss

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esra Gulen Yildiz

  Ankara Training and Resarch Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 15, 2021
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)