The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under Neuraxial Anesthesia to Inform Anesthetic Practice

NCT06589687 | Completed

• 1 other identifier: 24-08
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the patients' and providers' perspectives and inform future anesthetic practice for patients undergoing unexpected cesarean delivery (CD) under neuraxial anesthesia (NA). 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 NA. 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.

Conditions

Psychological Well Being

Keywords

cesarean delivery; patient experience; epidural

Outcome Measures

Primary Outcomes (2)

• Patient questionnaire

  Patients will be asked to rate their experience of having a cesarean delivery with neuraxial 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

  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).

Study Arms (1)

Unexpected cesarean delivery under neuraxial anesthesia

Patients who have an unexpected cesarean delivery under neuraxial anesthesia.

Other: Interview

Interventions

Interview OTHER

Patients will be interviewed by the research team to learn about their experience of Cesarean delivery under neuraxial anesthetic.

Unexpected cesarean delivery under neuraxial anesthesia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who deliver by unexpected cesarean section with neuraxial anesthesia at Mount Sinai Hospital.

You may qualify if:

• 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 CD that can be done with the existing or newly applied neuraxial anesthesia (specifically, without the need for general anesthesia) due to fetal or maternal emergencies (e.g., fetal bradycardia, pre-eclampsia, chorioamnionitis, etc.)
• uCD 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) CD 16
• 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

You may not qualify if:

• 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 CD will be excluded.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sabine Nabecker, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: January 7, 2025
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)