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CompletedNCT06589687PAS-EDU-uCD-NAUpdated Apr 1, 2026

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

An observational study in Psychological Well Being, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Completed at 1 site in Canada. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

Read the 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. Neuraxial anesthesia (NA) is the preferred anesthetic for CD because it has a better safety profile, avoids airway management, decreases blood loss, improves postoperative analgesia, and decreases neonatal drug exposure compared with general anesthesia.

NA allows the patient and partner to experience the delivery, enhancing parent-baby bonding, but has many well-described risks, including hypotension leading to nausea, shivering, post-dural puncture headache, nerve injury, and failure to achieve satisfactory anesthesia. If a CD is needed in a parturient with an existing labour epidural analgesia, it is common practice to convert or 'top-up' the epidural catheter, with the aim of initiating surgical anesthesia by injecting more concentrated local anesthetic (LA) solution, normally combined with a lipid-soluble opioid.

Patients' greatest concern during and after CD is pain. Childbirth is a profound experience with 1/3 of patients experiencing a highly stressful and potentially traumatic childbirth. A birthing parent's experience during a planned CD versus an unexpected CD (uCD) can play a role in the development of post-traumatic stress disorder (PTSD). Childbirth-related PTSD is estimated to affect 5-6% of all postpartum women. With CD representing 1/3 of all North American deliveries annually, uCDs will contribute to an increased risk of PTSD and post-partum depression (PPD) symptoms. Given the suffering associated with PPD and that women experiencing PPD incur greater health care costs, understanding the association between CD and associated traumatic birth experiences may help guide interventions to address both the psychosocial impact on families and the economic impacts on health care.

The concept of "patients as educators" is new to the practice of anesthesia and aims to embrace the patient perspective to guide quality improvement initiatives. This study will explore patients' perception of their experience with uCD under neuraxial anesthesia (uCD-NA) and aim to provide insight into patients' feelings, concerns and expectations after an unscheduled experience for childbirth. By adding the providers' perspective on the topic of childbirth via uCD-NA, the investigators will be able to explore differences and similarities in opinions, thoughts, feelings and concerns as well as wishes for their care between patients and their providers. Thus, the study will also aim to explore the perspective of anesthesiologists, anesthesia assistants/respiratory therapists, obstetricians and registered nurses.

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Conditions studied

  • Psychological Well Being

Keywords

  • cesarean delivery
  • patient experience
  • epidural
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In context

Psychological Well-Being

971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.

This study's enrollment of 25 is below the median of 235 across 131 observational studies indexed under Psychological Well-Being.

Browse Psychological Well-Being studies →

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 135 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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 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

Exclusion criteria

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 CD will be excluded.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • Unexpected cesarean delivery under neuraxial anesthesia

    Patients who have an unexpected cesarean delivery under neuraxial anesthesia.

    Other: Interview

Interventions

  • OtherInterview

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).

  2. 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.

    Time frame: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).

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Study locations

1 site
  • Mount Sinai Hospital
    Toronto, Ontario M5G1X5, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06589687
Lead sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Jan 7, 2025
Primary completion
Jun 19, 2025
Completion
Jun 19, 2025
Last update
Apr 1, 2026

Study contacts

Sabine Nabecker, MD
principal investigator · MOUNT SINAI HOSPITAL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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