The Effect of Enhanced Recovery After Surgery (ERAS) for Cesarean Section on Neonatal Blood Glucose

Study Overview
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Brief Summary
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Enhanced Recovery After Surgery (ERAS) is a set of evidence-based guidelines that may be used during perioperative care for cesarean section. While there is good evidence that following ERAS protocols benefits postoperative recovery, less is understood about the effect on the fetus and neonate. This will be a randomized equivalence trial to determine if drinking a carbohydrate rich drink prior to cesarean section has an effect on neonatal glucose.

Detailed Description
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Cesarean section is one of the most common surgeries performed today with over one million performed in the United States annually. Enhanced Recovery After Surgery (ERAS) is a standardized set of guidelines which has been utilized in multiple surgical disciplines, including colorectal, urologic, gynecologic, and hepatobiliary surgery. ERAS guidelines are now being adopted for the obstetric population and provide evidence-based guidelines for perioperative care for cesarean delivery. Part of the preoperative ERAS pathway includes the recommendation for oral administration of a carbohydrate- containing fluid prior to surgery. A Cochrane review found that across several trials, carbohydrate loading was associated with favorable outcomes such as decreased time to passage of gas and reduction in length of hospital stay. Maternal outcomes are improved due to the decrease in insulin resistance that perioperative carbohydrate loading provides. During surgery, the body enters a catabolic state leading to insulin resistance that may delay recovery. Preoperative carbohydrate drinks have also been given to patients with diabetes, and although the decrease in insulin resistance is less certain, there seems to be less risk of postoperative hyperglycemia and the practice is considered safe but needing more study. While it is clear that ERAS provides benefits to the mother, less is understood about the effects on the fetus and neonate. Fetal and neonatal glucose level is known to be strongly tied to the level of insulin resistance and glucose level in the mother, particularly in the immediate time period prior to birth. Neonatal hypoglycemia after delivery is an important determinate of health, as hypoglycemia has been linked to poor neurologic outcomes. Cesarean section is a known risk factor for neonatal hypoglycemia requiring IV dextrose with an odds ratio of 1.4. There are known risk factors for neonatal hypoglycemia, such as being the infant of a diabetic mother, preterm, weight <2500g, or >4500g, and poor feeding, however, the incidence of hypoglycemia in neonates with no clear risk factors is 5-15%. With health care systems adopting the ERAS protocol as part of the standardized guidelines for perioperative care, it will be important to understand the effect of carbohydrate loading on both maternal and neonatal glucose levels as well as other outcomes.

Official Title
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The Effect of Enhanced Recovery After Surgery (ERAS) for Cesarean Section on Neonatal Blood Glucose - A Randomized Equivalency Trial

Conditions
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Enhanced Recovery After Surgery, Cesarean Section

Intervention / Treatment
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* Dietary Supplement: Carbohydrate Preoperative Drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with term pregnancies Intact Amniotic membranes Not in labor Planned delivery by cesarean section Fluent in either English or Spanish Exclusion Criteria: Less than 18 years old In labor Not fasted at least 8 hours Did not do glucose screening during pregnancy Fetal anomalies History of galactosemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-diabetic Control<br>Patients without diabetes. No intervention will be administered - standard care. | |
| Experimental: Non-diabetic CHO Drink<br>Patients without diabetes. Commercially available preoperative carbohydrate drink will be administered two hours prior to cesarean section. | Dietary Supplement: Carbohydrate Preoperative Drink<br>* Patients randomized to the intervention will drink the preoperative drink two hours prior to surgery<br>|
| No Intervention: Diabetic Control<br>Patients with diabetes. No intervention will be administered - standard care. | |
| Experimental: Diabetic CHO Drink<br>Patients with diabetes. Commercially available preoperative carbohydrate drink will be administered two hours prior to cesarean section. | Dietary Supplement: Carbohydrate Preoperative Drink<br>* Patients randomized to the intervention will drink the preoperative drink two hours prior to surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal glucose (mg/dl) | Neonatal glucose (mg/dl) | 60-120 minutes of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal glucose 2 (mg/dl) | Neonatal glucose 2 (mg/dl) | 24 hours of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Neonatal hypoglycemia