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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2025-04-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Pre-operative Carbohydrate Loading Reduce Insulin Resistance and Improve Outcomes in Elective Surgical Patients?

NCT00618592

Coronary Artery Bypass Graft Surgery Spine Surgery

COMPLETED NA

Gastric Emptying and Insulin Response to Test Drink

NCT01971229

Insulin Resistance

COMPLETED NA

Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Adult Cardiac Surgery Patients

NCT07212153

Cardiac Surgery Insulin Resistance

COMPLETED NA

Role of Preoperative Carbohydrates Drinks, Dichloroacetate and Exercise on Postoperative Muscle Insulin Resistance

NCT02469337

Insulin Resistance

UNKNOWN PHASE4

Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level

NCT06376929

Postoperative Nausea and Vomiting

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Preoperative fasting and surgery can cause metabolic stress and insulin resistance. Perioperative insulin resistance results in hyperglycemia which can lead to increased infectious complications, morbidity, and mortality.2,3 Significant research has occurred in the non-pregnant population utilizing preoperative oral carbohydrate loading to attenuate the development of insulin resistance. In a recent meta-analysis, Awad and colleagues 2 found that a preoperative carbohydrate drink may be associated with reduced length of stay and a reduction in postoperative insulin resistance in patients undergoing major abdominal surgery.

Approximately 1.3 million women undergo cesarean delivery (CD) annually in the United States. 4 CD is the most common inpatient surgery in the United States. In the UK, there are recommendations to implement enhanced recovery after obstetric surgery. Implementation of enhanced recovery supports the National Health Service Quality, Innovation, Productivity, and Prevention programme with the aim of improving quality of care while reducing costs. As part of the enhanced recovery pathway, pregnant women are receiving a preoperative carbohydrate drink. There is a paucity of research looking at the metabolic effects of this carbohydrate load in the pregnant woman and her neonate.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fasting

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Carbohydrate Drink

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

Group Type EXPERIMENTAL

Carbohydrate Drink

Intervention Type DIETARY_SUPPLEMENT

2 - 12 oz drinks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carbohydrate Drink

2 - 12 oz drinks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Clearfast Preop Drink

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion:

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes