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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05494268
• Other study ID #: KaramanogluMehmeybeyU
• Status: Completed
• Start date: September 13, 2022
• Est. completion date: November 5, 2022

Study information

• Verified date: December 2022
• Source: Karamanoglu Mehmetbey University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 5, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Fetus
• Pregnancy Related

Intervention

Drug:
• Carbohydrate
Preoperative Carbohydrate Loading Drink

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Total ephedrine usage	At hypotensive episodes, 5 mg ephedrine will be used intravenously.	From beginning to the end of the surgery