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

Sponsor

University of Arizona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05081804

Collaborator

(none)

216

Enrollment

Location

Arms

26.3

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enhanced Recovery After Surgery Cesarean Section	Dietary Supplement: Carbohydrate Preoperative Drink	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Dietary Supplement: Carbohydrate Preoperative Drink Patients randomized to the intervention will drink the preoperative drink two hours prior to surgery
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.	Dietary Supplement: Carbohydrate Preoperative Drink Patients randomized to the intervention will drink the preoperative drink two hours prior to surgery

Outcome Measures

Primary Outcome Measures

Neonatal glucose (mg/dl) [60-120 minutes of life]
Neonatal glucose (mg/dl)

Secondary Outcome Measures

Neonatal glucose 2 (mg/dl) [24 hours of life]
Neonatal glucose 2 (mg/dl)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner University Medicial Center	Tucson	Arizona	United States	85719

Sponsors and Collaborators

University of Arizona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Karen Lesser, Associate Professor of Obstetrics and Gynecology, University of Arizona

ClinicalTrials.gov Identifier:

NCT05081804

Other Study ID Numbers:

ERAS-CS

First Posted:

Oct 18, 2021

Last Update Posted:

Oct 29, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karen Lesser, Associate Professor of Obstetrics and Gynecology, University of Arizona

ERAS

Neonatal hypoglycemia

Study Results

No Results Posted as of Oct 29, 2021