Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

Effects of Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section. A Double-Blind Placebo-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: preoperative carbohydrate loading; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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; Other Names: Experimental
Placebo Comparator: Placebo; The control group will receive plain water with the same volume and timing of treatment	Drug: Placebo; The control group will receive plain water with the same volume and timing of treatment.; Other Names: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Number of days in the hospital for each participant between the groups.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants experienced nausea	Number of participants experienced nausea	24 hours postoperative
Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale	100 mm visual analogue scales for hunger, thirst, anxiety, fatigue and nausea administered on the morning of surgery prior to morning beverage consumption and 60 minutes after the beverage. All measurements will be assessed using the same scale starting at 0 to 100mm with 0 being the worst and 100 being the best and average being 85.	ist 24 hours postoperative
neonatal blood glucose concentration at four and ten hours of age	measure neonatal blood glucose level at four and ten hours of age	24 hours post operative
Neonates with plasma glucose level of less than 45 mg/dL between the groups	First umbilical cord blood sample will be taken for plasma glucose level of less than 45 mg/dL to note hypoglycemia between the groups.	ist 24 hours postoperative

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: cesarean section; Enhanced recovery after surgery; Preoperative carbohydrate drink
• Other Study ID Numbers: aswu/197/7/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No