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临床试验/NCT04907292
NCT04907292已完成不适用

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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2021年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
试验地点
1
主要终点
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Opioid consumption - 24 hours(24 hours)
  • Pain Score (VAS) - 48 hours(48 hours)
  • Pain Score (VAS) - 24 hours(24 hours)
  • Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days(7 days)
  • Opioid consumption - 48 hours(48 hours)
  • Hospital discharge - questionnaire, 24 hours(24 hours)
  • Obstetric Quality of Recovery-10 (ObsQoR-10) score 48 hours(48 hours)
  • Hospital discharge - questionnaire, 48 hours(48 hours)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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