Gestational Diabetes Mellitus
Conditions
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.
Interventions
OTHERWHO (World Health Organisation)
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
OTHERIADPSG
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
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure the prevalence of GDM diagnosed using WHO versus IADPSG criteria | 14-37weeks | Prevalence of GDM will be reported in percentage for both groups- WHO and IADPSG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG) | 14-37 weeks | Number of incidence in each group will be reported in percentage: Primary caesarean section |
| To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG) | 14-37 weeks | Number of incidence will be reported in percentage: Macrosomia (BW\>90th centile for gestational age, gender and ethnicity) |
Countries
Malaysia
Contacts
Primary ContactNurul Basri, MBCHB
Outcome results
None listed