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

NCT ID: NCT05081804

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2024-12-31

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.

Conditions

Enhanced Recovery After Surgery; Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Non-diabetic Control

Patients without diabetes. No intervention will be administered - standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Non-diabetic CHO Drink

Patients without diabetes. Commercially available preoperative carbohydrate drink will be administered two hours prior to cesarean section.

Group Type: EXPERIMENTAL

Carbohydrate Preoperative Drink

Intervention Type: DIETARY_SUPPLEMENT

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

Diabetic Control

Patients with diabetes. No intervention will be administered - standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Diabetic CHO Drink

Patients with diabetes. Commercially available preoperative carbohydrate drink will be administered two hours prior to cesarean section.

Group Type: EXPERIMENTAL

Carbohydrate Preoperative Drink

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Carbohydrate Preoperative Drink

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Biomedical

INDUSTRY

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Karen Lesser

Associate Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Banner University Medicial Center

Tucson, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen Lesser, MD

Role: CONTACT

klesser@obgyn.arizona.edu

520-626-6174

Facility Contacts

Karen Lesser, MD

Role: primary

klesser@obgyn.arizona.edu

520-626-6174

References

Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614.

Reference Type: BACKGROUND

PMID: 24417824 (View on PubMed)

Fay EE, Hitti JE, Delgado CM, Savitsky LM, Mills EB, Slater JL, Bollag LA. An enhanced recovery after surgery pathway for cesarean delivery decreases hospital stay and cost. Am J Obstet Gynecol. 2019 Oct;221(4):349.e1-349.e9. doi: 10.1016/j.ajog.2019.06.041. Epub 2019 Jun 22.

Reference Type: BACKGROUND

PMID: 31238038 (View on PubMed)

Ge LN, Wang L, Wang F. Effectiveness and Safety of Preoperative Oral Carbohydrates in Enhanced Recovery after Surgery Protocols for Patients with Diabetes Mellitus: A Systematic Review. Biomed Res Int. 2020 Feb 18;2020:5623596. doi: 10.1155/2020/5623596. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32219135 (View on PubMed)

Harris DL, Weston PJ, Harding JE. Incidence of neonatal hypoglycemia in babies identified as at risk. J Pediatr. 2012 Nov;161(5):787-91. doi: 10.1016/j.jpeds.2012.05.022. Epub 2012 Jun 23.

Reference Type: BACKGROUND

PMID: 22727868 (View on PubMed)

Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;2014(8):CD009161. doi: 10.1002/14651858.CD009161.pub2.

Reference Type: BACKGROUND

PMID: 25121931 (View on PubMed)

Steenhagen E. Enhanced Recovery After Surgery: It's Time to Change Practice! Nutr Clin Pract. 2016 Feb;31(1):18-29. doi: 10.1177/0884533615622640. Epub 2015 Dec 24.

Reference Type: BACKGROUND

PMID: 26703956 (View on PubMed)

Turner D, Monthe-Dreze C, Cherkerzian S, Gregory K, Sen S. Maternal obesity and cesarean section delivery: additional risk factors for neonatal hypoglycemia? J Perinatol. 2019 Aug;39(8):1057-1064. doi: 10.1038/s41372-019-0404-z. Epub 2019 Jun 18.

Reference Type: BACKGROUND

PMID: 31213637 (View on PubMed)

Wilson RD, Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G. Guidelines for Antenatal and Preoperative care in Cesarean Delivery: Enhanced Recovery After Surgery Society Recommendations (Part 1). Am J Obstet Gynecol. 2018 Dec;219(6):523.e1-523.e15. doi: 10.1016/j.ajog.2018.09.015. Epub 2018 Sep 18.

Reference Type: BACKGROUND

PMID: 30240657 (View on PubMed)

Other Identifiers

ERAS-CS

Identifier Type: -

Identifier Source: org_study_id