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

Not Applicable

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: WHO (World Health Organisation); Other: IADPSG

• Registration Number: NCT02433262
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-05-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 506

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WHO (World Health Organisation)	WHO (World Health Organisation)	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	IADPSG	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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: Preterm delivery (\<37 weeks gestation)
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: Shoulder dystocia or birth injury

Trial Locations

Locations (1)

Obstetrics & Gynaecology Department, National University of Malaysia; 🇲🇾 Cheras, Kuala Lumpur, Malaysia