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

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ClinicalTrials.gov Identifier: NCT06333626
Recruitment Status : Not yet recruiting
First Posted : March 27, 2024
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Tracking Information
First Submitted Date  ICMJE March 13, 2024
First Posted Date  ICMJE March 27, 2024
Last Update Posted Date March 27, 2024
Estimated Study Start Date  ICMJE April 1, 2024
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2024)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2024)
  • vomiting [ Time Frame: During the cesarean section ]
    The number of times pregnant woman vomits during cesarean section
  • The pH of vomiting fluid [ Time Frame: During the cesarean section ]
    The pH of vomiting fluid recorded by a pen pH meter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting
Official Title  ICMJE Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting in Women Converted From Vaginal Delivery to Cesarean Section
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Nausea and Vomiting, Aspiration, Intraoperative
Intervention  ICMJE Dietary Supplement: multi-vitamin carbohydrate
oral multi-vitamin carbohydrate beverage
Study Arms  ICMJE
  • Experimental: Observation group
    Intervention: Dietary Supplement: multi-vitamin carbohydrate
  • No Intervention: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2024)		 90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jinli Xu +8613812016797 xujinli900208@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06333626
Other Study ID Numbers  ICMJE 2020281
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party The First Affiliated Hospital of Soochow University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The First Affiliated Hospital of Soochow University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital of Soochow University
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP