Cesarean Section ComplicationsMALTO-TCNCT05553756
Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section
A study testing Maltodextrin in people with Cesarean Section Complications, run by University of Foggia at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- informed consent
- first cesarean section
- single fetus
- ASA I-II
Who cannot join
- BMI<18
- BMI>35
- contraindication to spinal anesthesia
- cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Cesarean Section Complications
- Being tested
- Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaltodextrinDietary supplement
200 ml maltodextrin given 2 hours before cesarean section
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic stability
blood glucose levels <180 mg/dl
Measured: perioperative
hemodynamic stability
mean arterial pressure > 70 mmHg during perioperative time
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start13 Apr 2020
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Collaborators
- Casa Sollievo della Sofferenza IRCCS
- Responsible party
- Principal investigator, Cotoia Antonella, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553756
- Sponsor's protocol ID
- 08/CE
- Acronym
- MALTO-TC
- Status last verified
- Sep 2022
- First submitted
- 31 Mar 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cotoia A, Palladino T, Discenza A, Potenza AM, Salatto P, Montrano L, Basta A, Vaira P, Cinnella G. Impact of maltodestrin intake in elective caesarean section: A randomised study. Clin Nutr ESPEN. 2026 Jun;73:103308. doi: 10.1016/j.clnesp.2026.103308. Epub 2026 Apr 30.
PubMed 42066989
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maltodextrin, Given 2 Hours Before Cesarean Section, on Glycemic and Hemodynamic Management of Pregnant
- ClinicalTrials.gov ID
- NCT05553756
- Acronym / sponsor ID
- MALTO-TC / 08/CE
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Collaborators
- Casa Sollievo della Sofferenza IRCCS
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative clear liquid | No intervention | –Patients will drink 200 ml of clear liquid two hours before Cesarean section |
| preoperative maltodextrin | Active comparator | Dietary Supplement: MaltodextrinPatients will drink 200 ml of maltodexin two hours before Cesarean section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- informed consent
- first cesarean section
- single fetus
- ASA I-II
Key exclusion criteria (4 listed)
- BMI<18
- BMI>35
- contraindication to spinal anesthesia
- cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maltodextrin200 ml maltodextrin given 2 hours before cesarean section | Dietary supplement | preoperative maltodextrin |
Primary outcome
Glycemic stability
Time frame: perioperative
blood glucose levels <180 mg/dl
hemodynamic stability
Time frame: perioperative
mean arterial pressure > 70 mmHg during perioperative time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Derived from this study: PubMed 42066989Cotoia A, Palladino T, Discenza A, Potenza AM, Salatto P, Montrano L, Basta A, Vaira P, Cinnella G. Impact of maltodestrin intake in elective caesarean section: A randomised study. Clin Nutr ESPEN. 2026 Jun;73:103308. doi: 10.1016/j.clnesp.2026.103308. Epub 2026 Apr 30.
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin in people with Cesarean Section Complications, run by University of Foggia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic stability (time frame: perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.