Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in… (NCT07697651) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in Pregnant Women
Turkey (Türkiye)53 participantsStarted 2025-03-25
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • 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.
Exclusion Criteria:
* • 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pure-Tone Audiometry Hearing Thresholds After Spinal Anesthesia
Timeframe: : Baseline preoperative assessment to postoperative audiometric assessment at 48 hours after spinal anesthesia