Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section (MALTO-TC)

September 21, 2022 updated by: Cotoia Antonella, University of Foggia

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Foggia, Italy, 71122
        • University of Foggia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: preoperative clear liquid
Patients will drink 200 ml of clear liquid two hours before Cesarean section
ACTIVE_COMPARATOR: preoperative maltodextrin
Patients will drink 200 ml of maltodexin two hours before Cesarean section
Dietary supplement: Maltodextrin
200 ml maltodextrin given 2 hours before cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic stability
Time Frame: perioperative
blood glucose levels <180 mg/dl
perioperative
hemodynamic stability
Time Frame: perioperative
mean arterial pressure > 70 mmHg during perioperative time
perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Foggia

Collaborators

Casa Sollievo della Sofferenza IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 13, 2020

Primary Completion (ANTICIPATED)

November 30, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (ACTUAL)

September 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 08/CE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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