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

Completed

• Conditions: Fetus Fetus; Pregnancy Related; Cesarean Delivery Affecting Fetus
• Interventions: Drug: Carbohydrate

• Registration Number: NCT05494268
• Lead Sponsor: Karamanoğlu Mehmetbey University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-08-06
• Study First Submitted QC: 2022-08-06
• Study First Posted: 2022-08-09
• Study Start: 2022-09-13
• Primary Completion: 2022-10-30
• Study Completion: 2022-11-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental ( Carb Group)	Carbohydrate	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.

Primary Outcome Measures

Name	Time	Method
The comparison of the changes in thiol disulfide values between the groups	From beginning to two hours after the surgery	The native thiol, total thiol, disulfide, native thiol/total thiol ratio, disulfide/native thiol ratio, and disulfide/total thiol ratio will be determined.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karaman Training and Research Hospital; 🇹🇷 Karaman, Merkez, Turkey