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Completed

NCT Number: NCT05494268

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Karaman Training and Research Hospital

Karaman, Merkez, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate

Drug

Preoperative Carbohydrate Loading Drink

Primary outcomes

  1. The comparison of the changes in thiol disulfide values between the groups

    Time frame: 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 outcomes

  1. Incidence of intraoperative hypotension

    Time frame: 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.

  2. Total ephedrine usage

    Time frame: From beginning to the end of the surgery

    At hypotensive episodes, 5 mg ephedrine will be used intravenously.

Sponsors and collaborators

Lead sponsor

Karamanoğlu Mehmetbey University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2022
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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