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Clinical Trials/NCT05841693
NCT05841693
Completed
Phase 4

Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery- An Obsevational Study

Karamanoğlu Mehmetbey University1 site in 1 country100 target enrollmentMay 12, 2023

Overview

Phase
Phase 4
Intervention
Carbohydrate
Conditions
Quality of Life
Sponsor
Karamanoğlu Mehmetbey University
Enrollment
100
Locations
1
Primary Endpoint
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The establishment of the Enhanced Recovery After Cesarean protocols resulted in to the production of specific care pathways with the aim of optimizing recovery after cesarean delivery (CD) and to reduce the costs to the health care system. Carbohydrate rich fluids are offered in this aspect to enhance postoperative quality of recovery. The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on obstetric quality of recovery after elective cesarean section.

Detailed Description

The 10-item Obstetric Quality-of-Recovery scale is a validated patient-reported outcome questionnaire that evaluates recovery quality after delivery. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. The shortened pre-operative fasting period, in addition to the positive metabolic effects, enhance the post-operative recovery and shorten the hospital stay. Postoperatively, it is also crucial for the mother to heal rapidly and be able to care for her child on her own. Although a lot of effects of the preoperative carbohydrate loading has been studied yet, the OQR-10 scale and after carbohydrate loading has not been investigated yet. All mothers undergoing a planned CD in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive carbohydrate solution ( Carb Group) and the other will consume same amount of placebo fluid (Noncarb Group). The aim of this study is to determine the effect of carbonhydrate rich solutions on quality of recovery of parturients undergoing elective CD with Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool.

Registry
clinicaltrials.gov
Start Date
May 12, 2023
End Date
March 10, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Karamanoğlu Mehmetbey University
Responsible Party
Principal Investigator
Principal Investigator

Ozlem Dulger

Assist Prof

Karamanoğlu Mehmetbey University

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 years old and over
  • Term singleton pregnancy
  • Undergoing planned caesarean delivery at Karaman Training and Research Hospital
  • Patients who have given informed written consent

Exclusion Criteria

  • Patients who have refused, are unable to give or have withdrawn consent
  • Patients with American Society of Anesthesiologists (ASA) classification of 4 or greater
  • Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse
  • Patients who have refused spinal anesthesia, or those in whom it is contraindicated.
  • Pregnancy with preeclampsia or eclampsia
  • Pregnancy with gestational diabetes mellitus or diabetes mellitus

Arms & Interventions

Experimental ( Carb Group)

Preoperative education will be provided by researchers to the patients on the ward before fluid intake.Solid food and drinking will be forbidden after 24:00 p.m the day before surgery. The Carb group will consume carbonhydrate fluid two hours before the surgery.

Intervention: Carbohydrate

Standard Care (Non-carb Group)

Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food and drinking will be forbidden after 24:00 p.m the day before surgery.The Non-carb Group will consume same amount of placebo fluid as Carb Group two hours before the surgery

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 24 hours

ObsQoR-10 score at 24 hours after surgery for both parturients consumed carbohydrate rich solution or placebo fluid. 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.

Secondary Outcomes

  • Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days(7 days)
  • Obstetric Quality of Recovery-10 (ObsQoR-10) score 72 hours(72 hours)
  • Hospital discharge(7 days)

Study Sites (1)

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