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

• Sponsor: Ankara Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04845412
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 9.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes; Hearing Loss	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 Design

• Study Type: Observational
• Actual Enrollment: 114 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic and Non-diabetic Mothers: a Prospective, Controlled Study
• Actual Study Start Date: Jun 1, 2019
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Rate of Hearing loss [One year]

   Rate of newborns who failed hearing screening tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara Training and Research Hospital	Ankara	Altindag	Turkey	06230

Sponsors and Collaborators

• Ankara Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Esra Gulen Yıldız, Principal Investigator, Ankara Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04845412
• Other Study ID Numbers: CGDMP2020
• First Posted: Apr 15, 2021
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Esra Gulen Yıldız, Principal Investigator, Ankara Training and Research Hospital: Gestational diabetes; Hearing loss; Newborns
• Additional relevant MeSH terms: Hearing Loss; Deafness; Diabetes, Gestational

Study Results

No Results Posted as of Apr 19, 2021