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NOT YET RECRUITING
NCT07858084

Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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.

Official title: Perceived and Observed Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery: A Cross-Sectional Study

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

105

Start Date

2026-10

Completion Date

2027-12-31

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

OTHER

Observation of anesthesia consent encounter and postpartum questionnaire

A trained non-treating observer attends and rates the routine pre-operative anesthesia consent encounter (OPTION-5). The patient completes a questionnaire 24-48 hours postpartum (SDM-Q-9, Decisional Conflict Scale). No change to clinical care.

Locations (1)

BC Women's Hospital

Vancouver, British Columbia, Canada