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

NCT ID: NCT05494268

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-13

Study Completion Date

2022-11-05

Brief Summary

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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

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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.

Conditions

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Pregnancy Related Cesarean Delivery Affecting Fetus Fetus Fetus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Carbohydrate

Intervention Type DRUG

Preoperative Carbohydrate Loading Drink

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.

No interventions assigned to this group

Interventions

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Carbohydrate

Preoperative Carbohydrate Loading Drink

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karamanoğlu Mehmetbey University

OTHER

Sponsor Role lead

Responsible Party

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Ozlem Dulger

Assist Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ozlem Dulger, Assist Prof

Role: PRINCIPAL_INVESTIGATOR

Karaman Training and Research Hospital

Locations

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Karaman Training and Research Hospital

Karaman, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KaramanogluMehmeybeyU

Identifier Type: -

Identifier Source: org_study_id