The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean… (NCT06368570) | Clinical Trial Compass
CompletedNot Applicable
The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery
Canada25 participantsStarted 2024-04-25
Plain-language summary
This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. Similarly, the experience of the CD varies significantly between patients as there are many patient, surgical and anesthetic factors that interact to create the unique experience each patient has. This study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience of CD and to then use this information to enhance the quality of future anesthesia care for elective CD.
Patients who have undergone a routine CD will be approached the day following their delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study, which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of obstetricians, anesthesiologists and nurses with the goal of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during elective CD.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* aged 18 years or older
* ASA Physical Classification Score II or III
* elective CD (i.e. scheduled between 7am - 5pm) as per institutional standards (see below)
* patients who underwent the additional procedure of tubal ligation, salpingectomy or myomectomy (of uterine fibroid \<4cm) at the time of CD will be included as these are considered minor additional procedures
Exclusion Criteria:
* under 18 years of age
* unable to answer questions due to a language barrier or their mental state
* BMI at the time of delivery that falls in the super-morbidly obese category (BMI \> 55m-2)
* Patients who have underwent preterm delivery (under 37 weeks gestation), had a multiple gestation pregnancy or if there was presence of a significant fetal anomaly
* Anesthetic technique that significantly deviates from the institutional standards (see below\*) including patients who underwent elective CD under epidural or dural puncture epidural (DPE) technique
* Performance of myomectomy with fibroid size \>4cm at the time of CD
* Patients who underwent emergent CD as well as those who had contraindicated or failed neuraxial anesthesia and required general anesthesia for or during their CD will also be excluded.
* Institutional standards: spinal or combined spinal and epidural (CSE) with the standard dose of 1.8mL heavy bupivacaine 0.75% combined with intrathecal morphine 100-150 micrograms and fentanyl 10-15 micrograms. Administration of crystalloid co-loading at 10-15…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient questionnaire
Timeframe: Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
2
Patient interview
Timeframe: Following scheduled c-section delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Trial details
NCT IDNCT06368570
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital