The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under General Anesthesia to Inform Anesthetic Practice (PAS-EDU-uCD-GA)

March 31, 2026 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under General Anesthesia to Inform Anesthetic Practice. A Prospective Patient-centred Multidisciplinary Mixed-method. (PAS-EDU-uCD-GA)

This study aims to explore the patients' and providers' perspectives and inform future anesthetic practice for patients undergoing unexpected cesarean delivery (CD) under general anesthetic (GA). The consideration of patients' concerns, preferences, expectations, and suggestions may lead to enhanced patient satisfaction, compliance, and quality of care that future patients receive during unexpected CD under GA. The investigators will possibly be able to identify gaps in procedural performance that warrant further investigation during the second phase of this study which will contribute to improvement of overall patient care. During the third phase, educational material will be generated from patient insights and will be distributed to the Department of Anesthesia, Department of Obstetrics and Gynaecology, Labour and Delivery Nurses and team of Anesthesia Assistants and Respiratory Therapists.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cesarean delivery (CD) is a surgical procedure that allows for birth of a neonate through a laparotomy and hysterotomy and is the most common surgical procedure performed worldwide with 21% of all childbirths occurring via CD.

A single-shot spinal anesthesia is the most common technique for CD due to its simplicity, quality of sensory blockade and reliability, as well as because of the safety for the fetus. Nevertheless, there are clinical situation where general anesthesia is necessary. General anesthesia care in obstetric scenarios remains a serious concern because of a high failed intubation rate, accidental awareness, increasing association with postpartum depression requiring hospitalization, suicidal ideation and self-inflicted injury, and traumatic birth experiences. General anesthesia for CD might not be planned and pivoting to this unexpected type of anesthesia can be a traumatic experience for patients and their families. Patients may receive a GA for various reasons, including failed neuraxial anesthesia, hemodynamic instability, or critical fetal situations not amendable to neuraxial anesthesia.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X5
        • Mount Sinai 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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who deliver by unexpected cesarean section under general anesthesia at Mount Sinai Hospital.

Description

Inclusion Criteria:

  • aged 18 years or older
  • English language proficiency (as interviews will be performed in English)
  • ASA Physical Classification Score 2-5 +/- E
  • Emergency or Urgent Cesarean Delivery with the need for general anesthesia due to fetal or maternal emergencies (e.g., fetal bradycardia, HELLP syndrome, etc.)
  • Unexpected Cesarean Delivery is defined as Level 1 (Emergency - Immediate threat to life of woman or fetus) and Level 2 (Urgent - Maternal or fetal compromise which is not immediately life-threatening) Cesarean Deliveries.21
  • Patients will be included if they undergo preterm delivery (under 37 weeks of gestation, or are having a multiple gestation pregnancy, also, if there is a significant fetal anomaly present.

Exclusion criteria:

  • Under 18 years of age
  • Unable to answer questions due to a language barrier or because of their mental or physical state (e.g., intubated patients)
  • BMI at the time of delivery that falls in the super-morbidly obese category (BMI > 55 kg/m2)
  • Patients who underwent preterm delivery (under 32 weeks gestation)
  • Patients will be excluded if neonatal death has occurred.
  • Patients who were scheduled for an elective Cesarean Delivery, but had contraindicated or failed neuraxial anesthesia and required general anesthesia for or during their CD will be excluded.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Unexpected cesarean delivery under general anesthesia
Patients who have an unexpected cesarean delivery under general anesthesia.
Other: Interview
Patients will be interviewed by the research team to learn about their experience of Cesarean delivery under general anesthetic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient questionnaire
Time Frame: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Patients will be asked to rate their experience of having a cesarean delivery under general anesthesia, in terms of satisfaction and their experience with any discomfort. Some questions are yes/no, some are on a scale from 1-10, where 1 = not at all and 10 = totally agree, and some are open-ended. The questionnaire will take approximately 10 minutes to complete.
Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Patient interview
Time Frame: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Patients will be interviewed in person by a member of the research team and asked open ended questions. Interviews will be recorded, transcribed and coded for themes. Responses are not reported on any scale. The interview will take approximately 30 minutes to complete.
Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).

Collaborators and Investigators

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

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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 (Actual)

October 28, 2024

Primary Completion (Actual)

February 24, 2025

Study Completion (Actual)

February 24, 2025

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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