Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

• Sponsor: Aswan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03732404
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications	Drug: preoperative carbohydrate loading; Drug: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a randomized, placebo-controlled, study.This is a randomized, placebo-controlled, study.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Effects of Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section. A Double-Blind Placebo-controlled Study
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Length of hospital stay [3 weeks]

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

Secondary Outcome Measures

1. number of participants experienced nausea [24 hours postoperative]

   Number of participants experienced nausea

2. 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.

3. 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

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University	Aswan		Egypt	81528

Sponsors and Collaborators

• Aswan University Hospital

Investigators

• Principal Investigator: hany f sallam, md, Aswan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
• ClinicalTrials.gov Identifier: NCT03732404
• Other Study ID Numbers: aswu/197/7/18
• First Posted: Nov 6, 2018
• Last Update Posted: Aug 9, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by hany farouk, Principal Investigator, Aswan University Hospital: Enhanced recovery after surgery; Preoperative carbohydrate drink; cesarean section

Study Results

No Results Posted as of Aug 9, 2021