An observational study in Quality Improvement, Quality of Recovery From Anaesthesia and Cesarean Section, sponsored by Jewish General Hospital. Recruiting at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Jewish General Hospital · Observational
This study will evaluate the effect of fasting duration and elective c-section start time on the overall quality of recovery. Patients will be seen 24 hours after surgery to answer 11 questions on their overall recovery after surgery. Several factors will be tracked to determine their effect on recovery, with the primary variable of interesting
This is a prospective observational study aiming to evaluate the impact of fasting time before cesarean section on the quality of recovery after c-section. All patients presenting for elective cesarean section with low transverse incision, under spinal anesthesia will be considered for inclusion.
The primary outcome will be the ObsQoR-11 score approximately 24 hours after surgery. Secondary outcomes will include the presence of nausea, vomiting or retching during surgery, the volume of intravenous fluid administered, the dose of vasopressor administered, the pain scores two hours after surgery, and the dose of opioid used in the 24 hours after surgery.
The primary analysis will be a linear regression to determine if there is a statistically significant correlation between fasting time and the ObsQoR-11 score while factoring in the variables mentioned above. Secondary analyses will determine if the fasting duration correlates with a change in any of the eleven components of the ObsQoR-11 score or the secondary outcomes listed. In addition, the fasting data will be plotted against the ObsQoR-11 score to determine if an inflection point is present.
Ten observations will be obtained for each independent variable included in the model, for a total of 100 patients in the study.
392 studies on the registry are indexed under Fasting; 63 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 74 observational studies indexed under Fasting.
Browse Fasting studies →Jewish General Hospital is the lead sponsor of 97 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients presenting to the Jewish General Hospital for elective cesarean section under spinal anesthesia will be considered for inclusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Obstetric Quality of Recovery (ObsQoR-11)
Obstetric quality of recovery after c-section, which has been validated based on the total score of 11 questions, with total scores ranging from 0 to 110, where 0 is the worst, and 110 is the best.
Time frame: 3 months
Nausea & Vomitting
The presence of nausea vomiting or retching during or within 24 hours of surgery
Time frame: 24 hours
Numeric Rating Scale (NRS) Pain Score 2 hours after surgery
Rating of pain, on a scale where 0 is no pain, and 10 is the worst pain imaginable.
Time frame: 2 hours after surgery
Plan to share: Yes — Anonymized data
Supporting information: Study protocol, Statistical analysis plan
Time frame: After publication for two years
Started Mar 2025 (actual). Primary completion is estimated for Aug 2026, 16 months after the start.
Of 46 non-industry observational studies under Fasting, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 48. This study's planned 16 months is close to that.
Counting every sponsor, half of 48 studies reached it within 17 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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