Hearing Loss; Post-Dural Puncture Headache; Cesarean DeliveryNCT07697651
Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in Pregnant Women
An observational study of Hearing Loss; Post-Dural Puncture Headache; Cesarean Delivery, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study will evaluate postoperative hearing changes in women undergoing elective cesarean delivery under spinal anesthesia. Pure-tone audiometry will be performed before spinal anesthesia and at the predefined postoperative assessment time. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hearing Loss; Post-Dural Puncture Headache; Cesarean Delivery
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2025to 15 Sep 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of pregnant women scheduled for elective cesarean delivery under spinal anesthesia at Duzce Unıversıty Medical Faculty Hospital Eligible participants will be enrolled consecutively after providing written informed consent. All participants will undergo routine spinal anesthesia as part of standard clinical care. Pure-tone audiometry will be performed preoperatively and within 48 hours postoperatively. Participants will also be followed for 7 days after spinal anesthesia for the occurrence of post-dural puncture headache.
Who may be able to join
- • Women aged 18 years or older.
- Scheduled for elective cesarean delivery.
- Planned spinal anesthesia.
- ASA physical status I-II [revise if another ASA range is approved in the protocol].
- Ability to complete preoperative and postoperative pure-tone audiometry assessments.
- Provision of written informed consent.
Who cannot join
- • Pre-existing hearing loss, use of hearing aids, or inability to complete audiometric testing.
- History of chronic otologic disease, ear surgery, or active ear infection.
- Contraindication to spinal anesthesia.
- Conversion to general anesthesia before completion of the protocol assessments.
- Refusal to participate or withdrawal of consent.
- [Add any protocol-specific exclusions approved by the ethics committee, such as chronic headache disorder, hypertensive disease of pregnancy, or major perioperative hemorrhage, only if applicable.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational study will evaluate postoperative hearing changes in women undergoing elective cesarean delivery under spinal anesthesia. Pure-tone audiometry will be performed before spinal anesthesia and at the predefined postoperative assessment time. The incidence, onset time, and severity of post-dural puncture headache (PDPH) will also be assessed. The study aims to determine whether hearing threshold changes occur after spinal anesthesia and whether these changes are associated with PDPH.
Read the detailed description
Spinal anesthesia is routinely used for elective cesarean delivery. Dural puncture may be associated with cerebrospinal fluid pressure changes that can affect inner-ear fluid dynamics and may result in transient changes in hearing thresholds. Post-dural puncture headache is another clinically relevant complication that may reflect cerebrospinal fluid loss and pressure changes.
Eligible women scheduled for elective cesarean delivery under spinal anesthesia will be enrolled consecutively after providing written informed consent. Spinal anesthesia will be administered according to routine clinical practice, with no additional anesthetic intervention performed for research purposes. Demographic and perioperative variables, including spinal needle gauge, sensory block level, hemodynamic measurements, vasopressor use, and occurrence of post-dural puncture headache, will be recorded. Pure-tone audiometry will be performed before surgery and at the predefined postoperative assessment time. Postoperative hearing thresholds will be compared with baseline values, and their association with post-dural puncture headache will be evaluated.
- Keywords
- Spinal Anesthesia; Cesarean Section; Pure-Tone Audiometry; Hearing Threshold; Post-Dural Puncture Headache; Obstetric Anesthesia
- Medical subject headings
- Hearing Loss, Post-Dural Puncture Headache
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pure-Tone Audiometry Hearing Thresholds After Spinal Anesthesia
The primary outcome is the difference between preoperative and postoperative pure-tone audiometry thresholds at the tested frequencies in each ear. Hearing thresholds will be recorded in decibels hearing level (dB HL), and the change from baseline will be analyzed
Measured: : Baseline preoperative assessment to postoperative audiometric assessment at 48 hours after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start25 Mar 2025
- Primary completion10 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss; Post-Dural Puncture Headache; Cesarean DeliveryStudies of the same condition, open and under way.
- 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
- 53 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697651
- Sponsor's protocol ID
- 2024/224
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in Pregnant Women
- ClinicalTrials.gov ID
- NCT07697651
- Acronym / sponsor ID
- 2024/224
- Keywords
- Spinal Anesthesia; Cesarean Section; Pure-Tone Audiometry; Hearing Threshold; Post-Dural Puncture Headache; Obstetric Anesthesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 13 Jul 2026 (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 prospective observational study will evaluate postoperative hearing changes in women undergoing elective cesarean delivery under spinal anesthesia. Pure-tone audiometry will be performed before spinal anesthesia and at the predefined postoperative assessment time. The incidence, onset time, and severity of post-dural puncture headache (PDPH) will also be assessed. The study aims to determine whether hearing threshold changes occur after spinal anesthesia and whether these changes are associated with PDPH.
Detailed description
Spinal anesthesia is routinely used for elective cesarean delivery. Dural puncture may be associated with cerebrospinal fluid pressure changes that can affect inner-ear fluid dynamics and may result in transient changes in hearing thresholds. Post-dural puncture headache is another clinically relevant complication that may reflect cerebrospinal fluid loss and pressure changes.
Eligible women scheduled for elective cesarean delivery under spinal anesthesia will be enrolled consecutively after providing written informed consent. Spinal anesthesia will be administered according to routine clinical practice, with no additional anesthetic intervention performed for research purposes. Demographic and perioperative variables, including spinal needle gauge, sensory block level, hemodynamic measurements, vasopressor use, and occurrence of post-dural puncture headache, will be recorded. Pure-tone audiometry will be performed before surgery and at the predefined postoperative assessment time. Postoperative hearing thresholds will be compared with baseline values, and their association with post-dural puncture headache will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of pregnant women scheduled for elective cesarean delivery under spinal anesthesia at Duzce Unıversıty Medical Faculty Hospital Eligible participants will be enrolled consecutively after providing written informed consent. All participants will undergo routine spinal anesthesia as part of standard clinical care. Pure-tone audiometry will be performed preoperatively and within 48 hours postoperatively. Participants will also be followed for 7 days after spinal anesthesia for the occurrence of post-dural puncture headache.
Key inclusion criteria (6 listed)
- • Women aged 18 years or older.
Key exclusion criteria (6 listed)
- • Pre-existing hearing loss, use of hearing aids, or inability to complete audiometric testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pure-Tone Audiometry Hearing Thresholds After Spinal Anesthesia
Time frame: : Baseline preoperative assessment to postoperative audiometric assessment at 48 hours after spinal anesthesia
The primary outcome is the difference between preoperative and postoperative pure-tone audiometry thresholds at the tested frequencies in each ear. Hearing thresholds will be recorded in decibels hearing level (dB HL), and the change from baseline will be analyzed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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 Hearing Loss; Post-Dural Puncture Headache; Cesarean Delivery, run by Duzce University 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Pure-Tone Audiometry Hearing Thresholds After Spinal Anesthesia (time frame: : Baseline preoperative assessment to postoperative audiometric assessment at 48 hours after spinal anesthesia). 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 13 Jul 2026.