Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery (QoR-10)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Postoperative Pain; Breastfeeding; Postoperative Nausea
• Intervention / Treatment: Drug: Carbohydrate; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ozlem Dulger, Assist prof; Phone Number: + 90 338 226 20 00; Email: ozlem_dulger@yahoo.com.tr
• Study Contact Backup: Name: Betul Basaran, MD, DESA,; Phone Number: +90 338 226 20 00; Email: betulbasaran1@yahoo.com

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Carbohydrate; The experimental group of patients will consume the carbohydrate rich fluid 2 hours before the elective CD.; Other Names: Preoperative carbohydrate rich feeding solution
Placebo Comparator: 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	Drug: Placebo; The control group will be offered same amount of placebo fluid.; Other Names: Preoperative placebo fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstetric Quality of Recovery-10 (ObsQoR-10) score 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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstetric Quality of Recovery-10 (ObsQoR-10) score 72 hours	ObsQoR-10 score at 72 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.	72 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days	ObsQoR-10 score at 7 days 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.	7 days
Hospital discharge	The parturients will be discharged from the hospital after they met the discharge criteria. This parameter reported as number of days after the operation to the day in which the patient met discharge criteria.	7 days

Collaborators and Investigators

• Sponsor: Karamanoğlu Mehmetbey University
• Investigators: Principal Investigator: Ozlem Dulger, Assist Prof, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): March 10, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cesarean Delivery; Quality of Recovery; Preoperative Carbonhyrate Fluid
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Vomiting; Nausea; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 1111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data of the study will be shared on demand.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No