Clinical trial NCT04845412: Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic Mothers
Official title: Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic and Non-diabetic Mothers: a Prospective, Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Hearing Loss
Keywords: Gestational diabetes
Hearing loss
Newborns
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with gestational diabetes and women without diabetic pregnancy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Hearing loss
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
state: Altindag
Study officials:
affiliation: Ankara Training and Resarch Hospital
name: Esra Gulen Yildiz
role: PRINCIPAL_INVESTIGATOR
References: