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

March 20, 2024 updated by: The First Affiliated Hospital of Soochow University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Observation group
Dietary supplement: multi-vitamin carbohydrate
oral multi-vitamin carbohydrate beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one hour after eating, two hours after eating, and before entering operating room

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020281

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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