Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section

Not Applicable

Active, not recruiting

• Conditions: Cesarean Section Complications

• Registration Number: NCT05553756
• Lead Sponsor: University of Foggia

Brief Summary

The goal is to evaluate the glycemic and hemodynamic stability in patients undergoing caesarean section in patients treated with maltodextrins two hours before the cesarean section

Detailed Description

The patients undergoing elective cesarean section will be randomly divided in two groups: patients who drink 200 ml of clear liquid two hours before surgery or patients treated with 200 ml maltodextrins two hours before the surgery. The glycemic control will be done immediately before the maldodextrin administration and after the cesarean section by gluco stick. Standard hemodynamic monitoring ECG, Heart Rate, Blood pressure, Temperature, preipheral oxygen saturation will be done routinely.

Study Timeline

• Study Start: 2020-04-13
• Study First Submitted: 2022-03-31
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-23
• Last Update Posted: 2022-09-23
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• informed consent
• first cesarean section
• single fetus
• ASA I-II

Exclusion Criteria

• BMI<18
• BMI>35
• contraindication to spinal anesthesia
• cardiovascular diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Glycemic stability	perioperative	blood glucose levels \<180 mg/dl
hemodynamic stability	perioperative	mean arterial pressure \> 70 mmHg during perioperative time

Trial Locations

Locations (1)

University of Foggia; 🇮🇹 Foggia, Italy