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

NCT05494268 | Completed DMC

• 1 other identifier: KaramanogluMehmeybeyU
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Cesarean Delivery Affecting Fetus; Fetus Fetus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of intraoperative hypotension

  From beginning to the end of the surgery

• Total ephedrine usage

  From beginning to the end of the surgery

Study Arms (2)

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

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.

Interventions

Carbohydrate DRUG

Preoperative Carbohydrate Loading Drink

Experimental ( Carb Group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: only pregnant patients will be studies.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The term pregnant patients admitted to Karaman Training and Research Hospital

You may qualify if:

• Term pregnancies,
• Planned elective ceserean sections,
• Under spinal anesthesia,
• Pregnants who can read and write Turkish.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Merkez, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fetus-in-Fetu

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Twins, Conjoined; Abnormalities, Severe Teratoid; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ozlem Dulger, Assist Prof

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 9, 2022
• Study Start: September 13, 2022
• Primary Completion: October 30, 2022
• Study Completion: November 5, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

TU (1)