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临床试验/NCT06225557
NCT06225557Unknown不适用

Comparison of Outcome Between the Implementation of Enhanced Recovery After Elective Cesarean Section Protocol (ERACS) Versus Traditional Methods

Minia University0 个研究点目标入组 106 人开始时间: 2024年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
106
主要终点
Obstetric Quality of Recovery 11 score (ObsQoR-11)

研究概览

简要总结

The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient's outcome measures.

详细描述

The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient outcome measures. The primary outcome is the evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery 11 score (ObsQoR-11) at the time of discharge.

Secondary outcomes are the evaluation of peak numeric postoperative pain rating score within the postoperative hospital stay, total amount of postoperative opioid consumption, postoperative nausea, and vomiting impact score after 6 hours postoperatively and at time of discharge, patient satisfaction using Leiden perioperative care patient satisfaction questionnaire (LPPSq) at time of discharge, presence of post-cesarean ileus and Hospital length to achieve criteria for discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women ASA I to ASA II aged from 18 up to 40 years. With non-complicated pregnancy undergoing elective CS.

排除标准

  • -Age less than 18 years
  • Complications (wound infection, re-exploration, caesarean hysterectomies)
  • Recent documented use of opioids Allergy to any drug used during the study.-
  • Patients with severe heart diseases, cardiac arrhythmia and myocardial injury.
  • uncontrolled diabetic patient
  • Severe liver and kidney diseases
  • Coagulation defect

研究组 & 干预措施

Traditional methods

Experimental

Traditional methods in postoperative care for elective cesarean section will be followed.

干预措施: Traditional postoperative care (Other)

ERAS society guidlines

Experimental

The ERAS society guidelines for elective cesarean section will be followed.

干预措施: ERAS community recommendation (Other)

结局指标

主要结局

Obstetric Quality of Recovery 11 score (ObsQoR-11)

时间窗: before discharge or during 24 hour postoperatively

it is consisted of 11 questions covers four domains of recovery outcomes: physical comfort, emotional state, physical independence and care of the neonate, and pain ,each question taking score from 0 to 10 with 0 is the minimum score and 10 is the highest score and the maximum total score is 110 and the minimum total is 0 which is the worest quality of recovery

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Abdelrehim Attia Mohamed

Assistant lecturer

Minia University

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