Nausea and Vomiting, Aspiration, IntraoperativeNCT06333626
Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting
A study testing multi-vitamin carbohydrate in people with Nausea and Vomiting, Aspiration, Intraoperative, run by The First Affiliated Hospital of Soochow University.
Trial summary
Nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. Our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Nausea and Vomiting, Aspiration, Intraoperative
- What is being tested?
- multi-vitamin carbohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Mar 2025
- 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
- at least 37 weeks pregnant, had not eaten for at least 4 h before entering the delivery room, converted from vaginal delivery to cesarean section
Who cannot join
- gestational diabetes mellitus or gastroesophageal reflux disease, cesarean section performed under general anesthesia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting in Women Converted From Vaginal Delivery to Cesarean Section
Nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. Our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric ultrasound.
- Being tested
- multi-vitamin carbohydrate
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-vitamin carbohydrateDietary supplement
oral multi-vitamin carbohydrate beverage
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Experimental | Not described Receives: Dietary Supplement: multi-vitamin carbohydrate |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric antrum area
The gastric antrum area measured by gastric ultrasound
Measured: one hour after eating, two hours after eating, and before entering operating room
Secondary outcomes (2)
vomiting
The number of times pregnant woman vomits during cesarean section
Measured: During the cesarean section
The pH of vomiting fluid
The pH of vomiting fluid recorded by a pen pH meter
Measured: During the cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, Aspiration, IntraoperativeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333626
- Sponsor's protocol ID
- 2020281
- Status last verified
- Dec 2023
- First submitted
- 13 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting in Women Converted From Vaginal Delivery to Cesarean Section
- ClinicalTrials.gov ID
- NCT06333626
- Acronym / sponsor ID
- 2020281
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 27 Mar 2024 (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.
Nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. Our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric ultrasound.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | Experimental | Dietary Supplement: multi-vitamin carbohydrate |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- at least 37 weeks pregnant, had not eaten for at least 4 h before entering the delivery room, converted from vaginal delivery to cesarean section
Key exclusion criteria (1 listed)
- gestational diabetes mellitus or gastroesophageal reflux disease, cesarean section performed under general anesthesia
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 |
|---|---|---|
| multi-vitamin carbohydrateoral multi-vitamin carbohydrate beverage | Dietary supplement | Observation group |
Primary outcome
Gastric antrum area
Time frame: one hour after eating, two hours after eating, and before entering operating room
The gastric antrum area measured by gastric ultrasound
2 secondary outcomes
vomiting
Time frame: During the cesarean section
The pH of vomiting fluid
Time frame: During the cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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.
Questions about this trial
What is this clinical trial studying?
A study testing multi-vitamin carbohydrate in people with Nausea and Vomiting, Aspiration, Intraoperative, run by The First Affiliated Hospital of Soochow University.
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 1 inclusion and 1 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 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jinli Xu (+8613812016797, xujinli900208@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric antrum area (time frame: one hour after eating, two hours after eating, and before entering operating room). 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 27 Mar 2024.