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NCT07858084
Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery
Conditions: Shared Decision Making, Cesarean Section, Anesthesia, Obstetrical, Informed Consent
Sex: Female
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 105
Sponsor: University of British Columbia
Location: BC Women's Hospital Vancouver British Columbia
Summary
Shared decision-making (SDM) is the accepted ethical and legal standard for informed consent, but it is not known how it operates in anesthesia consent for cesarean delivery. Neuraxial anesthesia is recommended for most cesarean deliveries, and many anesthesiologists therefore present it as the only primary option, with general anesthesia (GA) available only as a rescue. Others present GA as a genuine alternative the patient can choose. This study will observe the existing variation in practice and will not change care. A trained observer will attend the pre-operative anesthesia consent encounter for women having an elective cesarean delivery at BC Women's Hospital and record which options were presented, using the observer-rated OPTION-5 instrument. Written research consent and a questionnaire follow 24-48 hours after delivery, and include the 9-item Shared Decision Making Questionnaire (SDM-Q-9). The primary aim is to compare patient-perceived SDM (SDM-Q-9) between consultations in which GA was offered as a genuine primary option and those in which it was not. We hypothesize that the SDM-Q-9 score will be higher when GA was offered as a primary option. Secondary aims are to describe observed SDM, decisional conflict, provider-level variation, and women's preference to be offered a choice in a future cesarean. The findings will inform a planned interventional trial of a standardized consent model.
Eligibility Criteria
Inclusion Criteria:
* Age 19 years or older
* Elective (scheduled) cesarean delivery at 37 weeks' gestation or later
* Anesthesia consent obtained on the day of surgery
* Anesthesia consent performed in English without an interpreter
* Capacity to consent to research participation
Exclusion Criteria:
* Conversion to urgent/emergency cesarean delivery before consent is completed
* Severe maternal or neonatal complication making participation inappropriate (assessed case by case with the clinical team)
* Contraindication to neuraxial anesthesia
* Patient declines observation pre-operatively, or declines or withdraws study consent postpartum
Source: ClinicalTrials.gov (NCT07858084). StuddyBuddy aggregates publicly available trial information.