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Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10

Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04907292
Enrollment
112
Registered
2021-05-28
Start date
2021-08-16
Completion date
2021-11-09
Last updated
2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Recovery

Keywords

Cesarean delivery, ObsQoR-10©

Brief summary

In Canada, 29.1% of annual births are via cesarean deliveries (CD). The literature shows that almost 24% of CDs are unplanned. Existing evidence suggests that unplanned cesarean delivery, compared to elective cesarean, may be associated with poor maternal recovery, longer postpartum hospital stays and more opioid requirements after surgery. Since the establishment of the Enhanced Recovery After Cesarean protocols, specific care pathways have been implemented with the aim of optimizing recovery after CD and to reduce the costs to the health care system. However, the majority of unplanned cesarean receive the same postoperative anesthetic, obstetric and nursing care as the elective CDs. Looking at the actual information about maternal recovery after unplanned CD, the investigators found that there is a paucity of literature examining this topic utilizing validated, patient-oriented quality of recovery tools. Recently, Obstetric Quality of Recovery-10 scoring tool (ObsQoR-10), a new patient-focused outcome instrument for postpartum recovery, it has been validated for all types of deliveries, in the inpatient setting. ObsQoR-10 tool aims to measure quantitatively functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient. The aim of this study is to determine the quality of recovery from unplanned cesarean deliveries compared to planned ones using a validated tool for recovery after cesarean delivery (ObsQoR-10 tool). The investigators hypothesize that quality of recovery as measured by the Obs-QoR10 for unplanned cesarean deliveries will be lower than the planned CDs.

Interventions

The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Women aged 18 years old and over * Term singleton pregnancy * Undergoing planned or unplanned caesarean delivery at Mount Sinai Hospital * Patients who have given informed written consent

Exclusion criteria

* Patients who have refused, are unable to give or have withdrawn consent * Patients unable to communicate fluently in English * Patients with American Society of Anesthesiologists (ASA) classification of 4 or greater * Patients scheduled to have a classical vertical incision * Patients undergoing cesarean hysterectomy * Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse * Patients who have refused neuraxial anesthesia, or those in whom it is contraindicated.

Design outcomes

Primary

MeasureTime frameDescription
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours24 hoursObsQoR-10 score at 24 hours after surgery for both planned and unplanned cesarean deliveries. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.

Secondary

MeasureTime frameDescription
Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days7 daysObsQoR-10 score at 7 days after surgery for both planned and unplanned cesarean deliveries. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.
Pain Score (VAS) - 24 hours24 hoursVerbal analogue scale (VAS) of 0-10, where 0= no pain and 10=worst pain imaginable, at 24 hours post cesarean delivery
Pain Score (VAS) - 48 hours48 hoursVerbal analogue scale (VAS) of 0-10, where 0= no pain and 10=worst pain imaginable, at 48 hours post cesarean delivery
Obstetric Quality of Recovery-10 (ObsQoR-10) score 48 hours48 hoursObsQoR-10 score at 48 hours after surgery for both planned and unplanned cesarean deliveries. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.
Opioid consumption - 48 hours48 hoursTotal opioid consumption within 48 hours post cesarean
Hospital discharge - questionnaire, 24 hours24 hoursAt 24 hours post cesarean, patients will be asked the question Are you ready to be discharged from the hospital? Yes or No
Hospital discharge - questionnaire, 48 hours48 hoursAt 48 hours post cesarean, patients will be asked the question Are you ready to be discharged from the hospital? Yes or No
Opioid consumption - 24 hours24 hoursTotal opioid consumption within 24 hours post cesarean

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026