The Impact of Fasting Duration on Quality of Recovery After Cesarean Section
NCT ID: NCT06701929
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-03-18
2026-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Urgent c-section
* Planned general anesthesia
FEMALE
No
Sponsors
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Jewish General Hospital
OTHER
Responsible Party
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Matthew Cameron, MDCM MPH
Associate Professor
Locations
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Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Kielty J, Borkowska A, Lawlor E, El-Khuffash AF, Doherty A, O'Flaherty D. Use of the Obstetric Quality-of-Recovery score (ObsQoR-11) to measure the impact of an enhanced recovery programme for elective caesarean section. Int J Obstet Anesth. 2024 Feb;57:103955. doi: 10.1016/j.ijoa.2023.103955. Epub 2023 Nov 10.
Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.
Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.
Other Identifiers
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ObsQoR-11 Survey (2025-4422)
Identifier Type: -
Identifier Source: org_study_id
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