Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity

NCT03494868 | Terminated

• 1 other identifier: 16-009567
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative fasting and surgery can cause metabolic stress and insulin resistance. Oral carbohydrate loading has been shown to attenuate the development of insulin resistance in the non-pregnant population undergoing many different types of surgery. Pregnant women have an increase in insulin resistance and therefore may further benefit from a preoperative carbohydrate load prior to cesarean delivery. Although woman in the UK receive a carbohydrate drink prior to elective cesarean delivery, the metabolic effects of these drinks on the mother and neonate have not been evaluated.

Conditions

Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Oral glucose tolerance test

  glucose, insulin

  24 hours postoperatively

Study Arms (2)

Fasting

NO INTERVENTION

Fasting prior to elective cesarean section delivery (standard of care)

Carbohydrate Drink

EXPERIMENTAL

Subjects will drink 2 carbohydrate drinks prior to elective cesarean section delivery

Dietary Supplement: Carbohydrate Drink

Interventions

Carbohydrate Drink DIETARY_SUPPLEMENT

2 - 12 oz drinks

Also known as: Clearfast Preop Drink

Carbohydrate Drink

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status II-III women presenting for scheduled, elective cesarean delivery under neuraxial anesthesia
• Singleton gestation at term (37-42 weeks)
• Ages 18-50

You may not qualify if:

• Preexisting diabetes (Gestational diabetes, Type I DM, Type II DM)
• Taking insulin-sensitizing or other medications known to influence glucose or fatty acid metabolism.
• Kidney, heart, or liver disease. Severe lipid disorders.
• History of bariatric surgery
• Pre-pregnancy BMI \>40
• Prolonged period of time (\>4 hours) between ingestion of carbohydrate drink and surgery
• Four or more repeat cesarean sections

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Emily E Sharpe, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: March 13, 2019
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)