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

Gestational Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02433262
• Other study ID #: FF-2015-067
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2015
• Last updated: May 1, 2017
• Start date: April 2015
• Est. completion date: March 2018

Study information

• Verified date: May 2017
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: Nurul Basri, MBCHB
• Phone: +60133452294
• Email: nurul.basri[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 506
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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
• 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

Locations

Country	Name	City	State
Malaysia	Obstetrics & Gynaecology Department, National University of Malaysia	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	14-37 weeks
Secondary	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	14-37 weeks
Secondary	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)	14-37 weeks
Secondary	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)	14-37 weeks
Secondary	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	14-37 weeks
Secondary	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	14-37 weeks