Effects of an Oral Multi-vitamin Carbohydrate Beverage on... | NCT06333626

Studies
Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting

NCT06333626

Sponsor

The First Affiliated Hospital of Soochow University

Status

Unknown status

Last Update Posted

Mar 27, 2024Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Nausea and Vomiting, Aspiration, Intraoperative

Interventions

multi-vitamin carbohydrate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Mar 31, 2025Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Mar 13, 2024

First Submission Date that Met QC Criteria

Mar 20, 2024

First Posted Date

Mar 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2024

Last Update Posted Date

Mar 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 ultrasound.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observation group	Experimental		Dietary Supplement: multi-vitamin carbohydrate
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multi-vitamin carbohydrate	Dietary Supplement	oral multi-vitamin carbohydrate beverage	Observation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastric antrum area	The gastric antrum area measured by gastric ultrasound	one hour after eating, two hours after eating, and before entering operating room

Secondary Outcomes

Measure	Description	Time Frame
vomiting	The number of times pregnant woman vomits during cesarean section	During the cesarean section
The pH of vomiting fluid	The pH of vomiting fluid recorded by a pen pH meter

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

gestational diabetes mellitus or gastroesophageal reflux disease, cesarean section performed under general anesthesia

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinli Xu	Contact	+8613812016797		xujinli900208@163.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided