Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery

NCT05841693 | Completed Phase 4 DMC

• 1 other identifier: 1111
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Breastfeeding; Postoperative Pain; Postoperative Nausea

Keywords

Cesarean Delivery; Quality of Recovery; Preoperative Carbonhyrate Fluid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Obstetric Quality of Recovery-10 (ObsQoR-10) score 72 hours

  72 hours

• Obstetric Quality of Recovery-10 (ObsQoR-10) score 7 days

  7 days

• Hospital discharge

  7 days

Study Arms (2)

Experimental ( Carb Group)

ACTIVE COMPARATOR

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

Standard Care (Non-carb Group)

PLACEBO COMPARATOR

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

Interventions

Carbohydrate DRUG

The experimental group of patients will consume the carbohydrate rich fluid 2 hours before the elective CD.

Also known as: Preoperative carbohydrate rich feeding solution

Experimental ( Carb Group)

Placebo DRUG

The control group will be offered same amount of placebo fluid.

Also known as: Preoperative placebo fluid

Standard Care (Non-carb Group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female patients undergoing electve cesarean delivery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding; Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Ozlem Dulger, Assist Prof

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients in CHO group will be offered carbohyrate rich preoperative fluid on the other hand the patients in Control Group will be offered placebo fluids resemble to carbohydrate rich preoperative drink. The investigators, care provider and outcome accessors also will be blinded to the group assignment of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Model Details: Randomized, double blinded

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 3, 2023
• Study Start: May 12, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 10, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)