The Impact of Fasting Duration on Quality of Recovery After Cesarean Section

NCT06701929 | Recruiting

• 1 other identifier: ObsQoR-11 Survey (2025-4422)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Quality Improvement; Quality of Recovery From Anaesthesia; Cesarean Section; Fasting ( 6H for Solid ; 2H for Clear Fluid )

Keywords

Quality of Recovery; cesarean section; fasting duration

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Nausea & Vomitting

  24 hours

• Numeric Rating Scale (NRS) Pain Score 2 hours after surgery

  2 hours after surgery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to the Jewish General Hospital for elective cesarean section under spinal anesthesia will be considered for inclusion.

You may qualify if:

• Presenting for elective c-section under spinal anesthesia

You may not qualify if:

• Unable to communicate in French or English
• Urgent c-section
• Planned general anesthesia

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 38030526 BACKGROUND

• 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.

  PMID: 33177330 BACKGROUND

• 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.

  PMID: 30579408 BACKGROUND

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Matthew Cameron, MDCM MPH

CONTACT

514-340-8222; matthew.cameron@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: March 18, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication for two years

Locations

CA (1)