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

NCT ID: NCT04907292

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-16

Study Completion Date

2021-11-09

Brief Summary

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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.

Detailed Description

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Conditions

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Quality of Recovery

Keywords

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Cesarean delivery ObsQoR-10©

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Planned Cesarean delivery

Patients who have an elective Cesarean delivery at Mount Sinai Hospital

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

Intervention Type 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.

Unplanned Cesarean delivery

Patients who have an unplanned Cesarean delivery at Mount Sinai Hospital

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

Intervention Type 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.

Interventions

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

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.

Intervention Type OTHER

Other Intervention Names

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ObsQoR-10©

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naveed Siddiqui, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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21-04

Identifier Type: -

Identifier Source: org_study_id