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

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ClinicalTrials.gov Identifier: NCT02433262
Recruitment Status : Unknown
Verified May 2017 by Universiti Kebangsaan Malaysia Medical Centre.
Recruitment status was:  Recruiting
First Posted : May 4, 2015
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Other: WHO (World Health Organisation) Other: IADPSG Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : April 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Diet control




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


  2. 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


  3. 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)


  4. 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)


  5. 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


  6. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433262


Contacts
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Contact: Nurul Basri, MBCHB +60133452294 nurul.basri@yahoo.co.uk

Locations
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Malaysia
Obstetrics & Gynaecology Department, National University of Malaysia Recruiting
Cheras, Kuala Lumpur, Malaysia, 56000
Contact: Nurul Iftida Basri, MBCHB    +60133452294    nurul.basri@yahoo.co.uk   
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre

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Responsible Party: Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT02433262     History of Changes
Other Study ID Numbers: FF-2015-067
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications