Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

Study Overview
=================
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.

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

Conditions
-----------------
Cesarean Section Complications

Intervention / Treatment
-----------------
* Drug: preoperative carbohydrate loading
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, placebo-controlled, study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative carbohydrate loading<br>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<br>* 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<br>* Other names: Experimental;|
| Placebo Comparator: Placebo<br>The control group will receive plain water with the same volume and timing of treatment | Drug: Placebo<br>* The control group will receive plain water with the same volume and timing of treatment.<br>* Other names: Placebo Comparator;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Number of days in the hospital for each participant between the groups. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants experienced nausea | 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 | 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enhanced recovery after surgery, Preoperative carbohydrate drink, cesarean section