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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Quality of Life, Breastfeeding, Postoperative Pain, Postoperative Nausea

Intervention / Treatment
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* Drug: Carbohydrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double blinded
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental ( Carb Group)<br>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<br>* The experimental group of patients will consume the carbohydrate rich fluid 2 hours before the elective CD.<br>* Other names: Preoperative carbohydrate rich feeding solution;|
| Placebo Comparator: Standard Care (Non-carb Group)<br>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<br>* The control group will be offered same amount of placebo fluid.<br>* Other names: Preoperative placebo fluid;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Delivery, Quality of Recovery, Preoperative Carbonhyrate Fluid