Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732404
• Other study ID #: aswu/197/7/18
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

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

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	Number of days in the hospital for each participant between the groups.	3 weeks
Secondary	number of participants experienced nausea	Number of participants experienced nausea	24 hours postoperative
Secondary	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
Secondary	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
Secondary	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