Comparing the Effects of Water Temperature and Actives in Glucose Solution on Pregnant Women

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus
• Interventions: Diagnostic Test: oral glucose tolerance test using water at room temperature; Diagnostic Test: oral glucose tolerance test using cold water; Diagnostic Test: oral glucose tolerance test using room temperature water with tea bag; Diagnostic Test: Oral glucose tolerance test using bubble water at room temperature; Diagnostic Test: oral glucose tolerance test using hot water with tea bag; Diagnostic Test: oral glucose tolerance test using cold water with tea bag; Diagnostic Test: oral glucose tolerance test using hot water; Diagnostic Test: Oral glucose tolerance test using bubble water

• Registration Number: NCT05508425
• Lead Sponsor: Chiayi Christian Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2022-07-05
• Study Completion: 2022-07-05
• Status Verified: 2022-08
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-17
• Last Update Submitted: 2022-08-17
• Study First Posted: 2022-08-19
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Pregnant women
• Gestational age between 24 and 28 weeks

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
water at room temperature	oral glucose tolerance test using water at room temperature	-
cold water	oral glucose tolerance test using cold water	-
room temperature water with tea bag	oral glucose tolerance test using room temperature water with tea bag	-
bubble water at room temperature	Oral glucose tolerance test using bubble water at room temperature	-
hot water with tea bag	oral glucose tolerance test using hot water with tea bag	-
cold water with tea bag	oral glucose tolerance test using cold water with tea bag	-
hot water	oral glucose tolerance test using hot water	-
cold bubble water	Oral glucose tolerance test using bubble water	-

Primary Outcome Measures

Name	Time	Method
Satisfaction after glucose solution administration	Just after glucose administration	Satisfaction was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).
Vomiting after glucose solution administration	Just 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)
gestational diabetes mellitus	At 2 hour after glucose administration	gestational diabetes mellitus at 2 hour after glucose administration.
Taste after glucose solution administration	Just after glucose administration	Taste was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).
Headache after glucose solution administration	Just 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)
Abdominal bloating after glucose solution administration	Just 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)
Glycaemia level	Glycaemia level was measured at 2 hours after glucose administration	Glycaemia level at 2 hour after glucose administration
Nausea after glucose solution administration	Just after glucose 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)

Trial Locations

Locations (1)

Ditmanson Medical Foundation Chia-Yi Christian Hospital; 🇨🇳 Chiayi City, Taiwan