Clinical trial NCT05494268: Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis
Official title: Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Cesarean Delivery Affecting Fetus
Fetus Fetus
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The term pregnant patients admitted to Karaman Training and Research Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: The comparison of the changes in thiol disulfide values between the groups
timeFrame: From beginning to two hours after the surgery
Secondary outcomes:
measure: Incidence of intraoperative hypotension
timeFrame: From beginning to the end of the surgery
measure: Total ephedrine usage
timeFrame: From beginning to the end of the surgery
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
state: Merkez
Study officials:
affiliation: Karaman Training and Research Hospital
name: Ozlem Dulger, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References: