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Enhanced Recovery After SurgeryNCT05081804

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

A study testing Carbohydrate Preoperative Drink in people with Enhanced Recovery After Surgery and Cesarean Section, run by University of Arizona at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Carbohydrate Preoperative Drink
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteUnited States
Study dates
20 Oct 2021to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Karen Lesser, MD contact

520-626-6174

klesser@obgyn.arizona.edu

United States1 site, 1 recruiting

  • Banner University Medicial Center

    Tucson, Arizona, 85719

    Karen Lesser, MD, 520-626-6174, klesser@obgyn.arizona.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Carbohydrate Preoperative Drink
Keywords
ERAS, Neonatal hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carbohydrate Preoperative DrinkDietary supplement

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

Study groups in NCT05081804
Study groupRoleWhat they receive
Non-diabetic ControlNo interventionPatients without diabetes. No intervention will be administered - standard care.
Non-diabetic CHO DrinkExperimentalPatients without diabetes. Commercially available preoperative carbohydrate drink will be administered two hours prior to cesarean section.
Receives: Dietary Supplement: Carbohydrate Preoperative Drink
Diabetic ControlNo interventionPatients with diabetes. No intervention will be administered - standard care.
Diabetic CHO DrinkExperimentalPatients with diabetes. Commercially available preoperative carbohydrate drink will be administered two hours prior to cesarean section.
Receives: Dietary Supplement: Carbohydrate Preoperative Drink

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal glucose (mg/dl)

    Neonatal glucose (mg/dl)

    Measured: 60-120 minutes of life

Secondary outcomes (1)

  1. Neonatal glucose 2 (mg/dl)

    Neonatal glucose 2 (mg/dl)

    Measured: 24 hours of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study start20 Oct 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05081804
Sponsor's protocol ID
ERAS-CS
Status last verified
May 2023
First submitted
4 Oct 2021
Last updated
17 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24417824

  • 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.

    PubMed 31238038

  • 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.

    PubMed 32219135

  • 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.

    PubMed 22727868

  • 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.

    PubMed 25121931

  • 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.

    PubMed 26703956

  • 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.

    PubMed 31213637

  • 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.

    PubMed 30240657

Questions about this trial

What is this clinical trial studying?

A study testing Carbohydrate Preoperative Drink in people with Enhanced Recovery After Surgery and Cesarean Section, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karen Lesser, MD (520-626-6174, klesser@obgyn.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal glucose (mg/dl) (time frame: 60-120 minutes of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05081804, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.

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