Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

NCT03732404 | Completed DMC

• 1 other identifier: aswu/197/7/18
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

Enhanced recovery after surgery; Preoperative carbohydrate drink; cesarean section

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Number of days in the hospital for each participant between the groups.

  3 weeks

Secondary Outcomes (4)

• 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

  ist 24 hours postoperative

• neonatal blood glucose concentration 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

  ist 24 hours postoperative

Study Arms (2)

preoperative carbohydrate loading

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

preoperative carbohydrate loading 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

Also known as: Experimental

preoperative carbohydrate loading

Placebo DRUG

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

Also known as: Placebo Comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant female scheduled for elective cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized, placebo-controlled, study.

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: November 6, 2018
• Study Start: December 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: August 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

EG (1)