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Behavioural Intervention

Unplanned Cesarean delivery for Quality of Recovery

N/A
Waitlist Available
Led By Naveed Siddiqui, MD
Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
Secondary study objectives
Hospital discharge - questionnaire, 24 hours
Hospital discharge - questionnaire, 48 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) score 48 hours
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Unplanned Cesarean deliveryExperimental Treatment1 Intervention
Patients who have an unplanned Cesarean delivery at Mount Sinai Hospital
Group II: Planned Cesarean deliveryExperimental Treatment1 Intervention
Patients who have an elective Cesarean delivery at Mount Sinai Hospital

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Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
128 Previous Clinical Trials
11,313 Total Patients Enrolled
Naveed Siddiqui, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
7 Previous Clinical Trials
643 Total Patients Enrolled
~27 spots leftby Sep 2025