Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis

Study Overview
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Brief Summary
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The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on thiol disulfide homeostasis when compared to standard care in elective cesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.

Detailed Description
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The concept of enhanced recovery after surgery (ERAS) has been gradually extended from surgery to the field of obstetrics. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. Although these effects of the preoperative carbohydrate loading has been studied, the thiol disulfide homeostasis effects after carbohydrate loading has not been investigated yet. Thiol-disulfide homeostasis (TDH) plays a critical role in the mechanisms of antioxidant defense, detoxification, apoptosis, regulation of enzyme activities, transcription, and cellular signal transduction. Since the newborns are very susceptible to harmfull effects of reactive oxygen species, the effect of carbohydrate loading on the reactive oxygen species gain importance. All mothers undergoing a planned caesarean section in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care.

Official Title
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Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis

Conditions
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Pregnancy Related, Cesarean Delivery Affecting Fetus, Fetus Fetus

Intervention / Treatment
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* Drug: Carbohydrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term pregnancies, Planned elective ceserean sections, Under spinal anesthesia, Pregnants who can read and write Turkish. Exclusion Criteria: Preterm pregnants, Pregnants with reflux, obesity, hiatus hernia, ileus, enteral nutrition, alcohol or substance abuse, prolonged delivery, systemic chronic diseases, malignancy, GDM,eclampsia,preeclampsia, fetal anomaliy, prolonged delivery

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental ( Carb Group)<br>Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. The Carb Group will consume carbohdrate fluid and Non-carb Group will consume equal amount of water at night and two hours before the surgery. | Drug: Carbohydrate<br>* Preoperative Carbohydrate Loading Drink<br>|
| Standart Care (Non-carb Group)<br>Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. The Carb Group will consume carbohdrate fluid and Non-carb Group will consume equal amount of water at night and two hours before the surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison of the changes in thiol disulfide values between the groups | The native thiol, total thiol, disulfide, native thiol/total thiol ratio, disulfide/native thiol ratio, and disulfide/total thiol ratio will be determined. | From beginning to two hours after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative hypotension | Hypotension is defined as a decrease in the mean arterial pressure by ˃20% of the baseline value. | From beginning to the end of the surgery | 
| Total ephedrine usage | At hypotensive episodes, 5 mg ephedrine will be used intravenously. | From beginning to the end of the surgery |