NCT05553756

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

2.6 years

First QC Date

March 31, 2022

Last Update Submit

September 21, 2022

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (2)

  • Glycemic stability

    blood glucose levels \<180 mg/dl

    perioperative

  • hemodynamic stability

    mean arterial pressure \> 70 mmHg during perioperative time

    perioperative

Study Arms (2)

preoperative clear liquid

NO INTERVENTION

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

preoperative maltodextrin

ACTIVE COMPARATOR

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

Dietary Supplement: Maltodextrin

Interventions

MaltodextrinDIETARY_SUPPLEMENT

200 ml maltodextrin given 2 hours before cesarean section

preoperative maltodextrin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Foggia

Foggia, 71122, Italy

Location

MeSH Terms

Interventions

maltodextrin

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 31, 2022

First Posted

September 23, 2022

Study Start

April 13, 2020

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations

IT(1)