Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
NCT Number: NCT06589687
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.
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Notify Me18 year–50 year
Female
Observational
Toronto, Ontario, M5G1X5, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be interviewed by the research team to learn about their experience of Cesarean delivery under neuraxial anesthetic.
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 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).
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.
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Other
The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under Neuraxial Anesthesia to Inform Anesthetic Practice. A Prospective Patient-centred Multidisciplinary Mixed-method. (PAS-EDU-uCD-NA)
Acronym: PAS-EDU-uCD-NA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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