NCT02433262

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
506

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

2.9 years

First QC Date

April 6, 2015

Last Update Submit

May 1, 2017

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

    14-37weeks

Secondary Outcomes (6)

  • To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)

    14-37 weeks

  • To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)

    14-37 weeks

  • To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)

    14-37 weeks

  • To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)

    14-37 weeks

  • To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)

    14-37 weeks

  • +1 more secondary outcomes

Study Arms (2)

WHO (World Health Organisation)

PLACEBO COMPARATOR

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)

IADPSG

ACTIVE COMPARATOR

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

Interventions

WHO (World Health Organisation)OTHER

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

Also known as: Diet control
WHO (World Health Organisation)
IADPSGOTHER

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

Also known as: Diet control
IADPSG

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to complete OGTT
  • Women previously diagnosed with Type 2 and Type 1 DM
  • Pregnant women who refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics & Gynaecology Department, National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

World Health Organization

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

United NationsInternational AgenciesOrganizationsHealth Care Economics and Organizations

Central Study Contacts

Nurul Basri, MBCHB

CONTACT

+60133452294nurul.basri@yahoo.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

May 4, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

MY(1)