Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

NCT ID: NCT03732404

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-08-01

Brief Summary

Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.

Detailed Description

Carbohydrate (sugar-containing) nutritional supplements have become a routine part of the package of care for people undergoing planned surgical procedures. the investigator wanted to discover whether carbohydrate supplements are a useful part of care packages used by doctors to improve recovery after planned cesarean section.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

preoperative carbohydrate loading

Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia

Group Type: EXPERIMENTAL

preoperative carbohydrate loading

Intervention Type: DRUG

Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia

Placebo

The control group will receive plain water with the same volume and timing of treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The control group will receive plain water with the same volume and timing of treatment.

Interventions

preoperative carbohydrate loading

Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia

Intervention Type: DRUG

Placebo

The control group will receive plain water with the same volume and timing of treatment.

Intervention Type: DRUG

Other Intervention Names

Experimental; Placebo Comparator

Eligibility Criteria

Inclusion Criteria

• Pregnant women undergoing elective caesarean section
• Term gestational age (37+0 to 41+6 weeks)
• Singleton gestation

Exclusion Criteria

• Women with gestational diabetes and diabetes mellitus
• Fetal intrauterine growth restriction
• Ante-natally detected congenital anomaly which will require admission to the neonatal nursery
• Women who received steroids within the past 7 days prior to delivery
• Women who did not complete a gestational diabetes screening test

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

Countries

Egypt

Other Identifiers

aswu/197/7/18

Identifier Type: -

Identifier Source: org_study_id