Recruiting

ERAS

Sponsor:

University of Arizona

Code:

NCT05081804

Conditions

Enhanced Recovery After Surgery

Cesarean Section

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Carbohydrate Preoperative Drink

Study Details

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

Study ID

NCT05081804

Start date

Oct 20, 2021

Status verified date

May, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Non-diabetic Control

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

experimental: Non-diabetic CHO Drink

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

no intervention: Diabetic Control

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

experimental: Diabetic CHO Drink

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

Interventions

Carbohydrate Preoperative Drink

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

Primary outcome measure

  • Neonatal glucose (mg/dl) [ Time Frame: 60-120 minutes of life ]

Central Contacts and Locations

Central contacts

Karen Lesser, MD

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

Locations

Banner University Medicial Center

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Karen Lesser, MD

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

More Information

Sponsor

University of Arizona

Last update posted

May 17, 2023

Last verified

May, 2023

Keywords

  • ERAS
  • Neonatal hypoglycemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2023-05-17.