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

216 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+