WHO Versus IADPSG Diagnostic Criteria of Gestational Diabetes Mellitus and Their Associated Maternal and Neonatal Outcomes

Study Overview
=================
Brief Summary
-----------------
Aim for this study is to measure the prevalence of Gestational Diabetes Mellitus (GDM) using World Health Organisation (WHO) versus International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria among pregnant mother in Universiti Kebangsaan Malaysia Medical Centre (UKMMC)

Detailed Description
-----------------
It will then be used to measure the incidence of adverse maternal and neonatal outcomes in women diagnosed with GDM using either of the criteria. Patients with risk factors for GDM will be recruited and randomised to either group once fulfilled the inclusion and exclusion criteria and agreed to join this study. Subjects will then undergo 75g oral glucose tolerance test and diagnosis will be established based on the group assigned.

Official Title
-----------------
World Health Organisation (WHO) Versus International Association of Diabetes and Pregnancy Study Group (IADPSG) Diagnostic Criteria of Gestational Diabetes Mellitus and Their Associated Maternal and Neonatal Outcomes

Conditions
-----------------
Gestational Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: WHO (World Health Organisation)
* Other: IADPSG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malaysian citizen and able to speak and understand Malay or English Pregnant women with one or more risk factors for GDM between 14-37 gestational weeks Singleton pregnancy Exclusion Criteria: Inability to complete OGTT Women previously diagnosed with Type 2 and Type 1 DM Pregnant women who refuse to participate
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: WHO (World Health Organisation)<br>Participants will undergo oral glucose tolerance test involving drinking of 75g glucose and blood taking for fasting and 2 hours post glucose intake. Diagnosis of GDM will be made based on these criteria: Fasting glucose >6 2 hour glucose >7.7 | Other: WHO (World Health Organisation)<br>* Participants will need to undergo oral glucose tolerance test which involve drinking a 75g oral glucose. Venous blood for fasting and 2 hours post glucose intake will be taken. Diagnosis of gestational diabetes mellitus (GDM) will be made using WHO criteria. Once GDM is diagnosed, they will undergo blood sugar profile monitoring and treatment which includes diet control and/or insulin treatment if required<br>* Other names: Diet control;|
| Active Comparator: IADPSG<br>Participants will undergo oral glucose tolerance test involving drinking of 75g glucose and blood taking for fasting and 2 hours post glucose intake. Diagnosis of GDM will be made based on these criteria: (International Association of Diabetes & Pregnancy Study Group) Fasting glucose >5 2 hour glucose >8.4 | Other: IADPSG<br>* Participants will need to undergo oral glucose tolerance test which involve drinking a 75g oral glucose. Venous blood for fasting and 2 hours post glucose intake will be taken. Diagnosis of gestational diabetes mellitus (GDM) will be made using IADPSG criteria. Once GDM is diagnosed, they will undergo blood sugar profile monitoring and treatment which includes diet control and/or insulin treatment if required<br>* Other names: Diet control;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the prevalence of GDM diagnosed using WHO versus IADPSG criteria | Prevalence of GDM will be reported in percentage for both groups- WHO and IADPSG | 14-37weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG) | Number of incidence in each group will be reported in percentage: Primary caesarean section | 14-37 weeks | 
| To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG) | Number of incidence in each group will be reported in percentage: Gestational hypertension or pre-eclampsia | 14-37 weeks | 
| To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG) | Number of incidence in each group will be reported in percentage: Preterm delivery (<37 weeks gestation) | 14-37 weeks | 
| To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG) | Number of incidence will be reported in percentage: Macrosomia (BW>90th centile for gestational age, gender and ethnicity) | 14-37 weeks | 
| To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG) | Number of incidence will be reported in percentage: Neonatal hypoglycaemia | 14-37 weeks | 
| To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG) | Number of incidence will be reported in percentage: Shoulder dystocia or birth injury | 14-37 weeks |