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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05494268
Enrollment
80
Registered
2022-08-09
Start date
2022-09-13
Completion date
2022-11-05
Last updated
2022-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery Affecting Fetus, Fetus Fetus, Pregnancy Related

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.

Interventions

DRUGCarbohydrate

Preoperative Carbohydrate Loading Drink

Sponsors

Karamanoğlu Mehmetbey University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The comparison of the changes in thiol disulfide values between the groupsFrom beginning to two hours after the surgeryThe native thiol, total thiol, disulfide, native thiol/total thiol ratio, disulfide/native thiol ratio, and disulfide/total thiol ratio will be determined.

Secondary

MeasureTime frameDescription
Incidence of intraoperative hypotensionFrom beginning to the end of the surgeryHypotension is defined as a decrease in the mean arterial pressure by ˃20% of the baseline value.
Total ephedrine usageFrom beginning to the end of the surgeryAt hypotensive episodes, 5 mg ephedrine will be used intravenously.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026