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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05081804
Enrollment
216
Registered
2021-10-18
Start date
2021-10-20
Completion date
2024-12-31
Last updated
2023-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Enhanced Recovery After Surgery

Keywords

ERAS, Neonatal hypoglycemia

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTCarbohydrate Preoperative Drink

Patients randomized to the intervention will drink the preoperative drink two hours prior to surgery

Sponsors

Nova Biomedical
CollaboratorINDUSTRY
University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Masking description

The providers taking care of the neonates will not know if the mother was randomized to receive the intervention (carbohydrate drink).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neonatal glucose (mg/dl)60-120 minutes of lifeNeonatal glucose (mg/dl)

Secondary

MeasureTime frameDescription
Neonatal glucose 2 (mg/dl)24 hours of lifeNeonatal glucose 2 (mg/dl)

Countries

United States

Contacts

Primary ContactKaren Lesser, MD
klesser@obgyn.arizona.edu520-626-6174

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026