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

Primary Purpose

Gestational Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
WHO (World Health Organisation)
IADPSG
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gestational Diabetes Mellitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Obstetrics & Gynaecology Department, National University of MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

WHO (World Health Organisation)

IADPSG

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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)
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)
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
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

Full Information

First Posted
April 6, 2015
Last Updated
May 1, 2017
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02433262
Brief Title
WHO Versus IADPSG Diagnostic Criteria of Gestational Diabetes Mellitus and Their Associated Maternal and Neonatal Outcomes
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
506 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WHO (World Health Organisation)
Arm Type
Placebo Comparator
Arm 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
Arm Title
IADPSG
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
WHO (World Health Organisation)
Other Intervention Name(s)
Diet control
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
IADPSG
Other Intervention Name(s)
Diet control
Intervention Description
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
Primary Outcome Measure Information:
Title
To measure the prevalence of GDM diagnosed using WHO versus IADPSG criteria
Description
Prevalence of GDM will be reported in percentage for both groups- WHO and IADPSG
Time Frame
14-37weeks
Secondary Outcome Measure Information:
Title
To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)
Description
Number of incidence in each group will be reported in percentage: Primary caesarean section
Time Frame
14-37 weeks
Title
To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)
Description
Number of incidence in each group will be reported in percentage: Gestational hypertension or pre-eclampsia
Time Frame
14-37 weeks
Title
To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)
Description
Number of incidence in each group will be reported in percentage: Preterm delivery (<37 weeks gestation)
Time Frame
14-37 weeks
Title
To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)
Description
Number of incidence will be reported in percentage: Macrosomia (BW>90th centile for gestational age, gender and ethnicity)
Time Frame
14-37 weeks
Title
To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)
Description
Number of incidence will be reported in percentage: Neonatal hypoglycaemia
Time Frame
14-37 weeks
Title
To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)
Description
Number of incidence will be reported in percentage: Shoulder dystocia or birth injury
Time Frame
14-37 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nurul Basri, MBCHB
Phone
+60133452294
Email
nurul.basri@yahoo.co.uk
Facility Information:
Facility Name
Obstetrics & Gynaecology Department, National University of Malaysia
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nurul Iftida Basri, MBCHB
Phone
+60133452294
Email
nurul.basri@yahoo.co.uk

12. IPD Sharing Statement

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

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