Clinical trial NCT04907292: Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10
Official title: Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Recovery
Keywords: Cesarean delivery
ObsQoR-10©
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who deliver by planned or unplanned cesarean section at Mount Sinai Hospital

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Obstetric Quality of Recovery-10 (ObsQoR-10) score 48 hours
timeFrame: 48 hours
measure: Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days
timeFrame: 7 days
measure: Pain Score (VAS) - 24 hours
timeFrame: 24 hours
measure: Pain Score (VAS) - 48 hours
timeFrame: 48 hours
measure: Opioid consumption - 24 hours
timeFrame: 24 hours
measure: Opioid consumption - 48 hours
timeFrame: 48 hours
measure: Hospital discharge - questionnaire, 24 hours
timeFrame: 24 hours
measure: Hospital discharge - questionnaire, 48 hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Naveed Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
References: