Carbohydrate Drink Before Cesarean Section for Newborn Blood Glucose

Overseen By Karen Lesser, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Under 18, Fetal anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a carbohydrate-rich drink before a planned cesarean section affects a newborn's blood sugar levels. Researchers aim to understand how this drink might aid mothers and their babies in recovering better after surgery. Participants will be divided into groups: some will receive the carbohydrate preoperative drink, while others will receive standard care. Pregnant women not in labor and planning a cesarean delivery may be suitable for this trial. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance recovery outcomes for mothers and babies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that drinks containing carbohydrates are generally well-tolerated by patients undergoing cesarean sections. These drinks can reduce feelings of thirst, hunger, and anxiety before surgery. They may also aid recovery by easing post-surgery discomfort and improving the body's insulin response.

No major side effects have been reported with these drinks. They are available for purchase and have been used safely in other medical situations. However, discussing any concerns or specific health conditions, such as diabetes, with a doctor before using these drinks is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a carbohydrate drink before a cesarean section because it could help stabilize newborn blood glucose levels more effectively than standard fasting protocols. Typically, patients fast before surgery, but this drink, taken two hours prior, provides a safe energy source that might prevent low blood sugar in newborns. This approach is particularly innovative because it offers a simple, non-invasive method to potentially improve outcomes for both diabetic and non-diabetic mothers and their babies.

What evidence suggests that this trial's treatments could be effective for neonatal glucose levels?

Research has shown that drinking a carbohydrate-rich beverage before a cesarean section can be beneficial. In this trial, some participants will receive a commercially available preoperative carbohydrate drink, while others will not receive any intervention. Studies have found that the drink reduces feelings of thirst and hunger in mothers and speeds up the return of normal gut function after surgery. It may also help stabilize blood sugar levels, which is important for recovery. However, limited evidence exists on its direct effect on newborns' blood sugar levels. Overall, it is considered helpful for mothers undergoing a cesarean, but its impact on newborns remains under study. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for non-laboring women over 18, planning a cesarean section at term with intact amniotic membranes, who speak English or Spanish. They must have fasted for at least 8 hours and completed glucose screening during pregnancy. Women in labor, with fetal anomalies, or a history of galactosemia cannot participate.

Inclusion Criteria

Intact Amniotic membranes

Not in labor

Planned delivery by cesarean section

Exclusion Criteria

In labor

Presence of fetal anomalies

Not fasted at least 8 hours

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Participants receive a carbohydrate-rich drink two hours prior to cesarean section as part of the ERAS protocol

2 hours

1 visit (in-person)

Surgery and Immediate Postoperative

Cesarean section is performed, and immediate postoperative care is provided

1 day

Inpatient stay

Follow-up

Participants are monitored for neonatal glucose levels and other outcomes

24 hours

Inpatient monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Carbohydrate Preoperative Drink

Trial Overview The study is testing if drinking a carbohydrate-rich drink before a cesarean section affects the baby's blood sugar levels after birth. It's an equivalence trial where participants are randomly chosen to either receive the drink or not before their surgery.

How Is the Trial Designed?

Group I: Non-diabetic CHO Drink Experimental Treatment 1 Intervention

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

Group II: Diabetic CHO Drink Experimental Treatment 1 Intervention

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

Group III: Diabetic Control Active Control 1 Intervention

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

Group IV: Non-diabetic Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Nova Biomedical

Industry Sponsor

Trials

11

Recruited

2,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10419905/

Preoperative Oral Carbohydrate (CHO) Supplementation Is ... Preoperative oral carbohydrate (CHO) supplementation is beneficial for clinical and biochemical outcomes in patients undergoing elective cesarean delivery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10999288/

Effects of Preoperative Oral Carbohydrate on Perioperative ... Preoperative oral CHO during cesarean section alleviates thirst and hunger, shortens the time of postoperative flatus, and reduces HOMA-IR.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05081804

The Effect of Enhanced Recovery After Surgery (ERAS) for ... 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.

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-021-04155-z

The impact of oral carbohydrate-rich supplement taken two ... Our finding showed that the administration of oral carbohydrate-rich solution 2 hours before caesarean delivery may not only reduce the maternal ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959289X20301369

Pre-operative carbohydrate loading prior to elective ... Pre-operative carbohydrate drinks can improve outcomes following major surgery. · Little evidence exists to support use prior to elective caesarean delivery.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04159948

NCT04159948 | Preoperative Carbohydrate Drink Prior to ... This study aims to assess the influence of pre-operative carbohydrate drinks on blood glucose levels of the baby at delivery.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959289X2500319X

The effect of preoperative carbohydrate loading on patients ... Oral carbohydrate loading reduces preoperative anxiety in patients scheduled for elective caesarean delivery.

8. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1403754/full

Enhanced recovery after surgery in elective cesarean ... Effects of carbohydrate load before cesarean section on intraoperative insulin resistance and neonatal blood glucose levels. Int J ...