Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

Not Applicable

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: preoperative carbohydrate loading; Drug: Placebo

• Registration Number: NCT03732404
• Lead Sponsor: Aswan University Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-03
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-06
• Study Start: 2018-12-01
• Primary Completion: 2021-06-30
• Status Verified: 2021-08
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preoperative carbohydrate loading	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
Placebo	Placebo	The control group will receive plain water with the same volume and timing of treatment

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	3 weeks	Number of days in the hospital for each participant between the groups.

Secondary Outcome Measures

Name	Time	Method
Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale	ist 24 hours postoperative	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.
neonatal blood glucose concentration at four and ten hours of age	24 hours post operative	measure neonatal blood glucose level at four and ten hours of age
Neonates with plasma glucose level of less than 45 mg/dL between the groups	ist 24 hours postoperative	First umbilical cord blood sample will be taken for plasma glucose level of less than 45 mg/dL to note hypoglycemia between the groups.
number of participants experienced nausea	24 hours postoperative	Number of participants experienced nausea

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt