Comparing the Effects of Water Temperature and Actives in Glucose Solution on Pregnant Women
1 other identifier
interventional
400
1 country
1
Brief Summary
To assess the effect of water temperature and additives on pregnant women's taste and side effect during the oral glucose tolerance test (OGTT) evaluation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2022
CompletedFirst Submitted
Initial submission to the registry
August 10, 2022
CompletedFirst Posted
Study publicly available on registry
August 19, 2022
CompletedAugust 19, 2022
August 1, 2022
8 months
August 10, 2022
August 17, 2022
Conditions
Outcome Measures
Primary Outcomes (12)
Glycaemia level
Glycaemia level just before glucose administration
Glycaemia level was measured just before glucose administration.
Glycaemia level
Glycaemia level at 1 hour after glucose administration
Glycaemia level was measured at 1 hour after glucose administration
Glycaemia level
Glycaemia level at 2 hour after glucose administration
Glycaemia level was measured at 2 hours after glucose administration
gestational diabetes mellitus
gestational diabetes mellitus just before glucose administration.
Just before glucose administration.
gestational diabetes mellitus
gestational diabetes mellitus at 1 hour after glucose administration.
At 1 hour after glucose administration
gestational diabetes mellitus
gestational diabetes mellitus at 2 hour after glucose administration.
At 2 hour after glucose administration
Satisfaction after glucose solution administration
Satisfaction was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).
Just after glucose administration
Taste after glucose solution administration
Taste was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).
Just after glucose administration
Nausea after glucose solution administration
Nausea was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)
Just after glucose administration
Vomiting after glucose solution administration
Vomiting was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)
Just after glucose solution administration
Headache after glucose solution administration
Headache was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)
Just after glucose solution administration
Abdominal bloating after glucose solution administration
Abdominal bloating was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)
Just after glucose solution administration
Study Arms (8)
water at room temperature
ACTIVE COMPARATORhot water
EXPERIMENTALcold water
EXPERIMENTALhot water with tea bag
EXPERIMENTALroom temperature water with tea bag
EXPERIMENTALcold water with tea bag
EXPERIMENTALbubble water at room temperature
EXPERIMENTALcold bubble water
EXPERIMENTALInterventions
The use of water at room temperature to solve the 75g glucose.
The use of hot water to solve the 75g glucose.
The use of cold water to solve the 75g glucose.
The use of hot water with tea bag to solve the 75g glucose.
The use of room temperature water with tea bag to solve the 75g glucose.
The use of cold water with tea bag to solve the 75g glucose.
The use of bubble water at room temperature to solve the 75g glucose.
The use of cold bubble water to solve the 75g glucose.
Eligibility Criteria
You may qualify if:
- Pregnant women
- Gestational age between 24 and 28 weeks
You may not qualify if:
- Clinical diagnosis of overt type 2 diabetes
- Clinical diagnosis of facial palsy
- Clinical diagnosis of oral cavity and throat
- Clinical diagnosis of hypothyroidism
- Clinical diagnosis of chronic hepatitis
- Clinical diagnosis of kidney disease .Clinical diagnosis of Sicca syndrome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, Taiwan
Related Publications (1)
Wang P, Chang PC, Wang CY, Wang LC, Shih CL. Comparing the effects of water temperature and additives in glucose solution on pregnant women's taste, side effects, and glycemic levels during an oral glucose tolerance test: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Apr;5(4):100870. doi: 10.1016/j.ajogmf.2023.100870. Epub 2023 Jan 20.
PMID: 36690181DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2022
First Posted
August 19, 2022
Study Start
November 1, 2021
Primary Completion
July 5, 2022
Study Completion
July 5, 2022
Last Updated
August 19, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share