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

May 1, 2017 updated by: Universiti Kebangsaan Malaysia Medical Centre

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

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

506

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Obstetrics & Gynaecology Department, National University of Malaysia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
Other: WHO (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
Other Names:
  • Diet control
Active Comparator: 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
Other: IADPSG
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
Other Names:
  • Diet control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the prevalence of GDM diagnosed using WHO versus IADPSG criteria
Time Frame: 14-37weeks
Prevalence of GDM will be reported in percentage for both groups- WHO and IADPSG
14-37weeks

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: 14-37 weeks

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)
Time Frame: 14-37 weeks

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)
Time Frame: 14-37 weeks

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)
Time Frame: 14-37 weeks

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)
Time Frame: 14-37 weeks

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)
Time Frame: 14-37 weeks

Number of incidence will be reported in percentage:

Shoulder dystocia or birth injury
14-37 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2015-067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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