Pregnancy RelatedNCT05494268
Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis
An observational study of Pregnancy Related and Cesarean Delivery Affecting Fetus, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on thiol disulfide homeostasis when compared to standard care in elective cesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Cesarean Delivery Affecting Fetus, Fetus Fetus
- What is being tested?
- Carbohydrate
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2022to 5 Nov 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The term pregnant patients admitted to Karaman Training and Research Hospital
Who may be able to join
- Term pregnancies,
- Planned elective ceserean sections,
- Under spinal anesthesia,
- Pregnants who can read and write Turkish.
Who cannot join
- Preterm pregnants,
- Pregnants with reflux,
- obesity,
- hiatus hernia,
- ileus,
- enteral nutrition,
Show all 13Show fewer
- alcohol or substance abuse,
- prolonged delivery,
- systemic chronic diseases,
- malignancy,
- GDM,eclampsia,preeclampsia,
- fetal anomaliy,
- prolonged delivery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, Merkez, 70200
About this study
The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on thiol disulfide homeostasis when compared to standard care in elective cesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.
Read the detailed description
The concept of enhanced recovery after surgery (ERAS) has been gradually extended from surgery to the field of obstetrics. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. Although these effects of the preoperative carbohydrate loading has been studied, the thiol disulfide homeostasis effects after carbohydrate loading has not been investigated yet. Thiol-disulfide homeostasis (TDH) plays a critical role in the mechanisms of antioxidant defense, detoxification, apoptosis, regulation of enzyme activities, transcription, and cellular signal transduction. Since the newborns are very susceptible to harmfull effects of reactive oxygen species, the effect of carbohydrate loading on the reactive oxygen species gain importance.
All mothers undergoing a planned caesarean section in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care.
- Being tested
- Carbohydrate
- Medical subject headings
- Fetus-in-Fetu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbohydrateDrug
Preoperative Carbohydrate Loading Drink
| Study group | Role | What they receive |
|---|---|---|
| Experimental ( Carb Group) | Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. The Carb Group will consume carbohdrate fluid and Non-carb Group will consume equal amount of water at night and two hours before the surgery. Receives: Drug: Carbohydrate | |
| Standart Care (Non-carb Group) | Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. The Carb Group will consume carbohdrate fluid and Non-carb Group will consume equal amount of water at night and two hours before the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of the changes in thiol disulfide values between the groups
The native thiol, total thiol, disulfide, native thiol/total thiol ratio, disulfide/native thiol ratio, and disulfide/total thiol ratio will be determined.
Measured: From beginning to two hours after the surgery
Secondary outcomes (2)
Incidence of intraoperative hypotension
Hypotension is defined as a decrease in the mean arterial pressure by ˃20% of the baseline value.
Measured: From beginning to the end of the surgery
Total ephedrine usage
At hypotensive episodes, 5 mg ephedrine will be used intravenously.
Measured: From beginning to the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start13 Sep 2022
- Primary completion30 Oct 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Dulger, Karamanoğlu Mehmetbey University
- Investigators
- Ozlem Dulger, Assist Prof, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494268
- Sponsor's protocol ID
- KaramanogluMehmeybeyU
- Status last verified
- Dec 2022
- First submitted
- 6 Aug 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All the results of the study will be shared on request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis
- ClinicalTrials.gov ID
- NCT05494268
- Acronym / sponsor ID
- KaramanogluMehmeybeyU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 9 Aug 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 primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on thiol disulfide homeostasis when compared to standard care in elective cesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.
Detailed description
The concept of enhanced recovery after surgery (ERAS) has been gradually extended from surgery to the field of obstetrics. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. Although these effects of the preoperative carbohydrate loading has been studied, the thiol disulfide homeostasis effects after carbohydrate loading has not been investigated yet. Thiol-disulfide homeostasis (TDH) plays a critical role in the mechanisms of antioxidant defense, detoxification, apoptosis, regulation of enzyme activities, transcription, and cellular signal transduction. Since the newborns are very susceptible to harmfull effects of reactive oxygen species, the effect of carbohydrate loading on the reactive oxygen species gain importance.
All mothers undergoing a planned caesarean section in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental ( Carb Group) | – | Drug: CarbohydratePreoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. The Carb Group will consume carbohdrate fluid and Non-carb Group will consume equal amount of water at night and two hours before the surgery. |
| Standart Care (Non-carb Group) | – | –Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. The Carb Group will consume carbohdrate fluid and Non-carb Group will consume equal amount of water at night and two hours before the surgery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The term pregnant patients admitted to Karaman Training and Research Hospital
Key inclusion criteria (4 listed)
- Term pregnancies,
- Planned elective ceserean sections,
- Under spinal anesthesia,
- Pregnants who can read and write Turkish.
Key exclusion criteria (13 listed)
- Preterm pregnants,
- Pregnants with reflux,
- obesity,
- hiatus hernia,
- ileus,
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 |
|---|---|---|
| CarbohydratePreoperative Carbohydrate Loading Drink | Drug | Experimental ( Carb Group) |
Primary outcome
The comparison of the changes in thiol disulfide values between the groups
Time frame: From beginning to two hours after the surgery
The native thiol, total thiol, disulfide, native thiol/total thiol ratio, disulfide/native thiol ratio, and disulfide/total thiol ratio will be determined.
2 secondary outcomes
Incidence of intraoperative hypotension
Time frame: From beginning to the end of the surgery
Total ephedrine usage
Time frame: From beginning to the end of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: Undecided. All the results of the study will be shared on request.
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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.
Ozlem Dulger, Assist Prof principal investigator
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Cesarean Delivery Affecting Fetus, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
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 13 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: finished, as of the sponsor's last update on 19 Dec 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The comparison of the changes in thiol disulfide values between the groups (time frame: From beginning to two hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2022.