Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section

NCT ID: NCT05553756

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-13

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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preoperative clear liquid

Patients will drink 200 ml of clear liquid two hours before Cesarean section

Group Type NO_INTERVENTION

No interventions assigned to this group

preoperative maltodextrin

Patients will drink 200 ml of maltodexin two hours before Cesarean section

Group Type ACTIVE_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

200 ml maltodextrin given 2 hours before cesarean section

Interventions

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Maltodextrin

200 ml maltodextrin given 2 hours before cesarean section

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* BMI\<18
* BMI\>35
* contraindication to spinal anesthesia
* cardiovascular diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Casa Sollievo della Sofferenza IRCCS

OTHER

Sponsor Role collaborator

University of Foggia

OTHER

Sponsor Role lead

Responsible Party

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Cotoia Antonella

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Foggia

Foggia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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08/CE

Identifier Type: -

Identifier Source: org_study_id

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