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NCT05553756 Clinical Trial

Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section

Cesarean Section Complications Clinical Trial

— MALTO-TC  

Official title:
Impact of Maltodextrin, Given 2 Hours Before Cesarean Section, on Glycemic and Hemodynamic Management of Pregnant

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05553756
Other study ID # 08/CE
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 13, 2020
Est. completion date December 31, 2022

Study information
Verified date September 2022
Source University of Foggia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date December 31, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Maltodextrin
200 ml maltodextrin given 2 hours before cesarean section

Locations
Country Name City State
Italy University of Foggia Foggia

Sponsors (2)
Lead Sponsor Collaborator
University of Foggia Casa Sollievo della Sofferenza IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glycemic stability blood glucose levels <180 mg/dl perioperative
Primary hemodynamic stability mean arterial pressure > 70 mmHg during perioperative time perioperative
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