Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

Aswan University Hospital

Status: Completed

Conditions: Cesarean Section Complications

Treatments: Drug: preoperative carbohydrate loading; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03732404

aswu/197/7/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

preoperative carbohydrate loading

Experimental group

Description:

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

Treatment:

Drug: preoperative carbohydrate loading

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo