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Clinical Trials in Turkey / NCT07697651
Active, not recruiting Observational

Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in Pregnant Women

NCT07697651 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-03-25
Last updated
2026-07-13

Condition(s) studied

Hearing Loss; Post-Dural Puncture Headache; Cesarean Delivery

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Duzce University Düzce Turkey (Türkiye)

More Duzce University trials in Turkey

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07697651 on ClinicalTrials.gov ↗ ← All trials in Turkey