Skip to main content
OpenTrials
Completed

NCT Number: NCT04907292

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool

Other

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.

Other names: ObsQoR-10©

Primary outcomes

  1. Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours

    Time frame: 24 hours

    ObsQoR-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 outcomes

  1. Obstetric Quality of Recovery-10 (ObsQoR-10) score 48 hours

    Time frame: 48 hours

    ObsQoR-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.

  2. Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days

    Time frame: 7 days

    ObsQoR-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.

  3. Pain Score (VAS) - 24 hours

    Time frame: 24 hours

    Verbal analogue scale (VAS) of 0-10, where 0= no pain and 10=worst pain imaginable, at 24 hours post cesarean delivery

  4. Pain Score (VAS) - 48 hours

    Time frame: 48 hours

    Verbal analogue scale (VAS) of 0-10, where 0= no pain and 10=worst pain imaginable, at 48 hours post cesarean delivery

  5. Opioid consumption - 24 hours

    Time frame: 24 hours

    Total opioid consumption within 24 hours post cesarean

  6. Opioid consumption - 48 hours

    Time frame: 48 hours

    Total opioid consumption within 48 hours post cesarean

  7. Hospital discharge - questionnaire, 24 hours

    Time frame: 24 hours

    At 24 hours post cesarean, patients will be asked the question "Are you ready to be discharged from the hospital? Yes or No"

  8. Hospital discharge - questionnaire, 48 hours

    Time frame: 48 hours

    At 48 hours post cesarean, patients will be asked the question "Are you ready to be discharged from the hospital? Yes or No"

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
Jan 31, 2022

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.

Published trials that share one or more normalized conditions with this study.