Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WHO (World Health Organisation) | Placebo Comparator | 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 |
|
| IADPSG | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WHO (World Health Organisation) | Other | 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 |
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nurul Basri, MBCHB | Contact | +60133452294 | nurul.basri@yahoo.co.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics & Gynaecology Department, National University of Malaysia | Recruiting | Cheras | Kuala Lumpur | 56000 | Malaysia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| IADPSG | Other | 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 |
|
|
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 |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014944 | World Health Organization |
| ID | Term |
|---|---|
| D014480 | United Nations |
| D007390 | International Agencies |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided