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

Study Overview
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Brief Summary
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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.

Official Title
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Comparing the Effects of Water Temperature and Actives in Glucose Solution on Pregnant Women's Taste and Side Effects During an Oral Glucose Tolerance Test-A Randomized Controlled Trial

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Diagnostic Test: oral glucose tolerance test using water at room temperature
* Diagnostic Test: oral glucose tolerance test using hot water
* Diagnostic Test: oral glucose tolerance test using cold water
* Diagnostic Test: oral glucose tolerance test using hot water with tea bag
* Diagnostic Test: oral glucose tolerance test using room temperature water with tea bag
* Diagnostic Test: oral glucose tolerance test using cold water with tea bag
* Diagnostic Test: Oral glucose tolerance test using bubble water at room temperature
* Diagnostic Test: Oral glucose tolerance test using bubble water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: water at room temperature<br> | Diagnostic Test: oral glucose tolerance test using water at room temperature<br>* The use of water at room temperature to solve the 75g glucose.<br>|
| Experimental: hot water<br> | Diagnostic Test: oral glucose tolerance test using hot water<br>* The use of hot water to solve the 75g glucose.<br>|
| Experimental: cold water<br> | Diagnostic Test: oral glucose tolerance test using cold water<br>* The use of cold water to solve the 75g glucose.<br>|
| Experimental: hot water with tea bag<br> | Diagnostic Test: oral glucose tolerance test using hot water with tea bag<br>* The use of hot water with tea bag to solve the 75g glucose.<br>|
| Experimental: room temperature water with tea bag<br> | Diagnostic Test: oral glucose tolerance test using room temperature water with tea bag<br>* The use of room temperature water with tea bag to solve the 75g glucose.<br>|
| Experimental: cold water with tea bag<br> | Diagnostic Test: oral glucose tolerance test using cold water with tea bag<br>* The use of cold water with tea bag to solve the 75g glucose.<br>|
| Experimental: bubble water at room temperature<br> | Diagnostic Test: Oral glucose tolerance test using bubble water at room temperature<br>* The use of bubble water at room temperature to solve the 75g glucose.<br>|
| Experimental: cold bubble water<br> | Diagnostic Test: Oral glucose tolerance test using bubble water<br>* The use of cold bubble water to solve the 75g glucose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |