Gestational DiabetesGDMNCT05152589
Maternal Diabetes in Newborns With Hearing Loss
An observational study of Gestational Diabetes and Pregestational Diabetes, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the presence and characteristics of maternal diabetes as a risk factor in newborns with hearing loss. Hearing loss is one of the most common congenital anomalies among newborns. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Pregestational Diabetes, Hearing Loss
- What is being tested?
- hearing test
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Jun 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: NEWBORNS WHO CANNOT PASS THE HEARING TEST APPLIED AS ROUTINE SCREENING
Who may be able to join
- POSTNATAL AGE BETWEEN 0-28 DAYS
- BIRTH WEIGHT ≥2000GR
- TO HAVE TESTED ON THE NEWBORN HEARING SCREENING UNIT AT ANKARA CITY HOSPITAL
Who cannot join
- PRETERMS
- CRANIOFACIAL ANOMALIES
- INTRAUTERINE INFECTIONS
- BIRTH WEIGHT <2000 GR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Newborn Hearing Loss
This study aims to investigate the presence and characteristics of maternal diabetes as a risk factor in newborns with hearing loss.
Hearing loss is one of the most common congenital anomalies among newborns. The newborn hearing screening program is important for early diagnosis in newborns with hearing loss.Gestational diabetes, on the other hand, is a metabolic disease that occurs during pregnancy and can cause complications as in other diabetes mellitus patients.
Read more
Despite our knowledge of major complications, the effect of the hyperglycemic intrauterine environment on hearing outcomes has not been adequately studied. The inner ear does not store energy, so it has a particularly high sensitivity to altered blood sugar and insulin. Altered inner ear metabolism leads to auditory and balance disorders.
There is no study in the literature comparing uncomplicated gestational diabetes and pregestational diabetes as a prenatal complication that poses a risk of hearing loss.
- Conditions
- Gestational Diabetes, Pregestational Diabetes, Hearing Loss
- Being tested
- hearing test
- Medical subject headings
- Diabetes, Gestational, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing testDiagnostic test
Also called ABR
Auditory Brainstem Response (ABR) Test
| Study group | Role | What they receive |
|---|---|---|
| gestational diabetic mother | Hearing tests of the babies of pregnant women who are being followed up with the diagnosis of gestational diabetes in the peritanotogy clinic Receives: Diagnostic Test: hearing test | |
| pregestational diabetic mother | Hearing tests of the babies of pregnant women who are being followed up with the diagnosis of pregestational diabetes in the peritanotogy clinic Receives: Diagnostic Test: hearing test | |
| non diabetic mother | Hearing tests of babies whose mothers do not have gestational or pregestational diabetes Receives: Diagnostic Test: hearing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Loss
Hearing test results in babies with no diabetes, pregestational diabetes, and gestational diabetes
Measured: 6 months
Secondary outcomes (1)
diabetic mother
Evaluation of classification tests by separating them from subgroups according to mothers' control times, usage controls, and glycemic viewers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152589
- Sponsor's protocol ID
- E2-21-1070
- Acronym
- GDM
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newborn Hearing Loss
- ClinicalTrials.gov ID
- NCT05152589
- Acronym / sponsor ID
- GDM / E2-21-1070
- Conditions
- Gestational Diabetes, Pregestational Diabetes, Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the presence and characteristics of maternal diabetes as a risk factor in newborns with hearing loss.
Hearing loss is one of the most common congenital anomalies among newborns. The newborn hearing screening program is important for early diagnosis in newborns with hearing loss.Gestational diabetes, on the other hand, is a metabolic disease that occurs during pregnancy and can cause complications as in other diabetes mellitus patients.
Despite our knowledge of major complications, the effect of the hyperglycemic intrauterine environment on hearing outcomes has not been adequately studied. The inner ear does not store energy, so it has a particularly high sensitivity to altered blood sugar and insulin. Altered inner ear metabolism leads to auditory and balance disorders.
There is no study in the literature comparing uncomplicated gestational diabetes and pregestational diabetes as a prenatal complication that poses a risk of hearing loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| gestational diabetic mother | – | Diagnostic Test: hearing testHearing tests of the babies of pregnant women who are being followed up with the diagnosis of gestational diabetes in the peritanotogy clinic |
| pregestational diabetic mother | – | Diagnostic Test: hearing testHearing tests of the babies of pregnant women who are being followed up with the diagnosis of pregestational diabetes in the peritanotogy clinic |
| non diabetic mother | – | Diagnostic Test: hearing testHearing tests of babies whose mothers do not have gestational or pregestational diabetes |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- NEWBORNS WHO CANNOT PASS THE HEARING TEST APPLIED AS ROUTINE SCREENING
Key inclusion criteria (3 listed)
- POSTNATAL AGE BETWEEN 0-28 DAYS
- BIRTH WEIGHT ≥2000GR
- TO HAVE TESTED ON THE NEWBORN HEARING SCREENING UNIT AT ANKARA CITY HOSPITAL
Key exclusion criteria (4 listed)
- PRETERMS
- CRANIOFACIAL ANOMALIES
- INTRAUTERINE INFECTIONS
- BIRTH WEIGHT <2000 GR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hearing testAlso: ABRAuditory Brainstem Response (ABR) Test | Diagnostic test | gestational diabetic mother, non diabetic mother, pregestational diabetic mother |
Primary outcome
Hearing Loss
Time frame: 6 months
Hearing test results in babies with no diabetes, pregestational diabetes, and gestational diabetes
1 secondary outcome
diabetic mother
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Pregestational Diabetes, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing Loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.