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

National University of Malaysia (UKM)

Status: Unknown

Conditions: Gestational Diabetes Mellitus

Treatments: Other: WHO (World Health Organisation); Other: IADPSG

Study type: Interventional

Funder types: Other

Identifiers

NCT02433262

FF-2015-067

Details and patient eligibility

About

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)

Full 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.

Enrollment: 506 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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506 participants in 2 patient groups, including a placebo group

WHO (World Health Organisation)

Placebo Comparator group

Description:

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

Treatment:

Other: WHO (World Health Organisation)

IADPSG

Active Comparator group

Description:

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

Treatment:

Other: IADPSG