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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Cesarean Delivery Affecting Fetus; Fetus Fetus
• Intervention / Treatment: Drug: Carbohydrate

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The term pregnant patients admitted to Karaman Training and Research Hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental ( Carb Group); 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; Preoperative Carbohydrate Loading Drink
Standart Care (Non-carb Group); 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?

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

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): September 13, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): November 5, 2022

Study Registration Dates

• First Submitted: August 6, 2022
• First Submitted That Met QC Criteria: August 6, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: KaramanogluMehmeybeyU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: All the results of the study will be shared on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No