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

NCT05081804 | Unknown

• 1 other identifier: ERAS-CS
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery After Surgery; Cesarean Section

Keywords

ERAS; Neonatal hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Neonatal glucose (mg/dl)

  Neonatal glucose (mg/dl)

  60-120 minutes of life

Secondary Outcomes (1)

• Neonatal glucose 2 (mg/dl)

  24 hours of life

Study Arms (4)

Non-diabetic Control

NO INTERVENTION

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

Non-diabetic CHO Drink

EXPERIMENTAL

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

Dietary Supplement: Carbohydrate Preoperative Drink

Diabetic Control

NO INTERVENTION

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

Diabetic CHO Drink

EXPERIMENTAL

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

Dietary Supplement: Carbohydrate Preoperative Drink

Interventions

Carbohydrate Preoperative Drink DIETARY_SUPPLEMENT

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

Diabetic CHO Drink; Non-diabetic CHO Drink

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with term pregnancies
• Intact Amniotic membranes
• Not in labor
• Planned delivery by cesarean section
• Fluent in either English or Spanish

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• Nova Biomedical: collaborator

Study Sites (1)

Banner University Medicial Center

Tucson, Arizona, 85719, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 24417824 BACKGROUND

• 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.

  PMID: 31238038 BACKGROUND

• 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.

  PMID: 32219135 BACKGROUND

• 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.

  PMID: 22727868 BACKGROUND

• 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.

  PMID: 25121931 BACKGROUND

• 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.

  PMID: 26703956 BACKGROUND

• 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.

  PMID: 31213637 BACKGROUND

• 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.

  PMID: 30240657 BACKGROUND

Central Study Contacts

Karen Lesser, MD

CONTACT

520-626-6174; klesser@obgyn.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The providers taking care of the neonates will not know if the mother was randomized to receive the intervention (carbohydrate drink).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: October 20, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)