Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery (SDM-Consent)

October 5, 2026 updated by: Ilana Sebbag, University of British Columbia

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

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. This study hypothesizes 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background. SDM, in which the clinician contributes evidence and the patient contributes values and preferences, is the ethical and increasingly the legal standard of consent (Hopp v Lepp; Reibl v Hughes; Montgomery v Lanarkshire). Major guidelines recommend neuraxial anesthesia for cesarean delivery because of the higher maternal risk of GA, and the SOAP Center of Excellence benchmark is a GA rate below 5%. Choice of technique is nevertheless preference-sensitive (being awake or asleep at the birth, partner presence, fear of needles or of awareness, prior trauma), and GA is routinely delivered when clinically required. Neuraxial block fails in about 5% of cesarean deliveries and intraoperative pain occurs in roughly 11-22%, a leading cause of maternal dissatisfaction and medicolegal action. The institutional consent discloses these risks. What varies between providers is choice: some present GA as a genuine primary option alongside neuraxial anesthesia, while others present neuraxial as the sole primary technique with GA only as rescue. A departmental poll found that 6 of 21 anesthesiologists (29%) report offering GA as a primary option. It is unknown whether offering GA as a genuine primary option affects women's perception of SDM.

Design. Single-centre, prospective, cross-sectional study at BC Women's Hospital, Vancouver. It combines (a) structured direct observation of the pre-operative anesthesia consent encounter and (b) a patient questionnaire on the 1st or 2nd postpartum day. No change is made to clinical care or to the consent process; existing variation in practice is the exposure. Because the anesthesiologist is assigned by the duty rota, women are quasi-randomly exposed to consent with or without a genuine primary choice.

Recruitment. A member of the circle of care (admitting nurse) asks the patient on the day of surgery whether they are willing to be approached. Only if they agree does a trained observer introduce the study and seek verbal assent to observation. Written informed consent is obtained 24-48 hours postpartum by a trained research assistant who is not the observer. The clinical anesthesia consent (routine care, observed) and the research consent (written, not observed) are separate processes. Providers receive an individual information sheet with an opt-out, and no per-case feedback is given. The specific exposure of interest is withheld from providers until study end; providers are not deceived about being observed.

Measures. Exposure: observer-classified offer of GA as a genuine primary option (yes/no). Observed SDM: OPTION-5, with at least 10% double-rated. Perceived SDM: SDM-Q-9 (primary outcome). Decisional conflict: Decisional Conflict Scale, descriptive. Future-choice preference. Covariates: age, parity, prior cesarean, prior anesthesia experience, education, gestational age, technique received, consultation duration.

Sample size and analysis. The primary analysis is a linear mixed-effects model with a random intercept for consenting provider, adjusted for covariates, reporting the adjusted mean difference with its 95% CI and the provider-level ICC. Assuming SD 12.4, alpha 0.05, a difference of 13.5 points, and ICC 0.10, 84 analyzable patients (4 per provider across 21 providers) give 97.7% power. Allowing about 20% attrition, the recruitment target is 105. A blinded biostatistician check of ICC, exposure split and SD after the first 105 patients will verify power; any increase in sample size will be submitted to the REB as an amendment. Reporting follows STROBE.

Data. Data are held in the institutional BCCHR/PHSA-hosted REDCap instance, keyed by study ID, with the re-identification key stored separately. Records are retained for 5 years after study completion and publication.

Study Type

Observational

Enrollment (Estimated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged 19 or older having an elective cesarean delivery at 37 weeks or later at BC Women's Hospital, with anesthesia consent obtained on the day of surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GA offered as a primary option

Women whose observed pre-operative anesthesia consent presented general anesthesia as a genuine primary option the patient could choose, alongside neuraxial anesthesia. Classified per consultation by the trained observer.
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.
Neuraxial only, GA as rescue

Women whose observed pre-operative anesthesia consent presented neuraxial anesthesia as the sole primary technique, with general anesthesia available only as a rescue.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-perceived shared decision-making (SDM-Q-9 score)
Time Frame: Post-operative day 1 or 2

Between-group difference in SDM-Q-9 total score (0-45), (higher = greater perceived involvement), between women whose consent included GA as a genuine primary option and those whose consent did not. Analysed with a linear mixed-effects model with a random intercept for consenting provider.
Post-operative day 1 or 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion with adequate SDM-Q-9 score
Time Frame: Post-operative day 1 or 2

Proportion of patients with an adequate 9-item Shared-Decision Making Score (SDM-Q-9,) score 0-45, transformed to a 0-100% scale, and using the top-box method to determine adequate (>75%) vs inadequate (<75%) scores, compared between exposure groups.
Post-operative day 1 or 2
Observed shared decision-making (OPTION-5)
Time Frame: Day of surgery, within 15 minutes of the consent encounter

Observer-rated OPTION-5 score (0-20), with higher scores meaning higher observed levels of shared-decision making between provider and patient, overall and by exposure group, with concordance with the SDM-Q-9.
Day of surgery, within 15 minutes of the consent encounter
Provider variability in offering choice
Time Frame: Day of surgery, at the consent encounter

Proportion of consultations in which a genuine primary choice was offered; between-provider variation (ICC); whether offers were provider-initiated or prompted by patient questions; disclosure elements delivered.
Day of surgery, at the consent encounter
Decisional conflict (Decisional Conflict Scale, 16-item)
Time Frame: Post-operative day 1 or 2

DCS score by exposure group, reported descriptively (mean, 95% CI, proportion above 37.5, and floor proportion).
Post-operative day 1 or 2
Preference for future choice
Time Frame: Post-operative day 1 or 2

Proportion of women who would want to be offered a choice between neuraxial and general anesthesia in a future cesarean, overall and by exposure group and technique received.
Post-operative day 1 or 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 29, 2026

First Submitted That Met QC Criteria

September 29, 2026

First Posted (Actual)

October 5, 2026

Study Record Updates

Last Update Posted (Actual)

October 8, 2026

Last Update Submitted That Met QC Criteria

October 5, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H26-02365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is currently no plan to share individual participant data (IPD). De-identified data may be made available if required by a journal as a condition of publication, subject to institutional, ethical, and privacy requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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