Gestational Diabetes MellitusNCT02433262
WHO Versus IADPSG Diagnostic Criteria of Gestational Diabetes Mellitus and Their Associated Maternal and Neonatal Outcomes
A study testing WHO (World Health Organisation) and IADPSG in people with Gestational Diabetes Mellitus, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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) Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- WHO (World Health Organisation) and IADPSG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 506 participants
- Where
- 1 siteMalaysia
- Study dates
- Apr 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to complete OGTT
- Women previously diagnosed with Type 2 and Type 1 DM
- Pregnant women who refuse to participate
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Obstetrics & Gynaecology Department, National University of Malaysia
Cheras, Kuala Lumpur, 56000
Nurul Iftida Basri, MBCHB, +60133452294, nurul.basri@yahoo.co.uk
About this study
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
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)
Read the 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- WHO (World Health Organisation), IADPSG
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO (World Health Organisation)Other
Also called Diet control
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
IADPSGOther
Also called Diet control
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: IADPSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Number of incidence in each group will be reported in percentage:
Primary caesarean section
Measured: 14-37 weeks
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
Measured: 14-37 weeks
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)
Measured: 14-37 weeks
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)
Measured: 14-37 weeks
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
Measured: 14-37 weeks
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
Measured: 14-37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433262
- Sponsor's protocol ID
- FF-2015-067
- Status last verified
- May 2017
- First submitted
- 6 Apr 2015
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02433262
- Acronym / sponsor ID
- FF-2015-067
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHO (World Health Organisation) | Placebo comparator | Other: 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 |
| IADPSG | Active comparator | Other: IADPSGParticipants 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to complete OGTT
- Women previously diagnosed with Type 2 and Type 1 DM
- Pregnant women who refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO (World Health Organisation)Also: Diet controlParticipants 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 | WHO (World Health Organisation) |
| IADPSGAlso: Diet controlParticipants 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 | IADPSG |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO (World Health Organisation) and IADPSG in people with Gestational Diabetes Mellitus, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurul Basri, MBCHB (+60133452294, nurul.basri@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the prevalence of GDM diagnosed using WHO versus IADPSG criteria (time frame: 14-37weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.