Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000266662
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Metformin in Gestational Diabetes
Scientific title
Gestational Diabetes: pregnancy outcomes in treatment with metformin compared with insulin.
Secondary ID [1] 130 0
Perinatal Trials Registry: PTR521
Universal Trial Number (UTN)
Trial acronym
MiG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes 353 0
Condition category
Condition code
Metabolic and Endocrine 413 413 0 0
Diabetes
Reproductive Health and Childbirth 414 414 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women with gestational diabetes requiring treatment are randomised to insulin or metformin treatment for the duration of pregnancy.
Intervention code [1] 308 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 473 0
Composite of neonatal morbidity including hypoglycaemia, respiratory distress, prematurity, phototherapy birth trauma, and low Apgar.
Timepoint [1] 473 0
At 5 minutes
Secondary outcome [1] 1027 0
Maternal glycaemia control
Timepoint [1] 1027 0
Secondary outcome [2] 1028 0
Neonatal anthropometry
Timepoint [2] 1028 0
Secondary outcome [3] 1029 0
Cord blood measures of adipoinsular axis
Timepoint [3] 1029 0
Secondary outcome [4] 1030 0
Maternal hypertensive complications and postpartum GTT results
Timepoint [4] 1030 0
Secondary outcome [5] 1031 0
Acceptability of treatments.
Timepoint [5] 1031 0

Eligibility
Key inclusion criteria
22-33 weeks' gestation, singleton pregnancy, capillary glucose levels requiring additional treatment.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes diagnosed pregnancy, gestational hypertension, pre-eclampsia of fetal growth restriction at study entry, fetal congenital anomaly, maternal medical conditon posing contra-indication to metformin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Data entered into computer and randmisation online
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
clinical trials unit programmed computer with sequence blocks for each site, as stratified by site
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment outside Australia
Country [1] 152 0
New Zealand
State/province [1] 152 0

Funding & Sponsors
Funding source category [1] 462 0
Government body
Name [1] 462 0
Human Research Council
Country [1] 462 0
New Zealand
Funding source category [2] 463 0
Government body
Name [2] 463 0
Medical Research Council Aust (NHMRC)
Country [2] 463 0
Australia
Funding source category [3] 464 0
Charities/Societies/Foundations
Name [3] 464 0
Auckland Medical Research Foundation
Country [3] 464 0
New Zealand
Funding source category [4] 465 0
Charities/Societies/Foundations
Name [4] 465 0
National Women's Charitable Trust
Country [4] 465 0
Primary sponsor type
Commercial sector/Industry
Name
HRC
Address
Country
Secondary sponsor category [1] 375 0
Government body
Name [1] 375 0
NHMRC, AMRF NWH
Address [1] 375 0
Country [1] 375 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1435 0
Auckland
Ethics committee address [1] 1435 0
Ethics committee country [1] 1435 0
New Zealand
Date submitted for ethics approval [1] 1435 0
Approval date [1] 1435 0
Ethics approval number [1] 1435 0
Ethics committee name [2] 1436 0
Wellington
Ethics committee address [2] 1436 0
Ethics committee country [2] 1436 0
New Zealand
Date submitted for ethics approval [2] 1436 0
Approval date [2] 1436 0
Ethics approval number [2] 1436 0
Ethics committee name [3] 1437 0
Christchurch
Ethics committee address [3] 1437 0
Ethics committee country [3] 1437 0
New Zealand
Date submitted for ethics approval [3] 1437 0
Approval date [3] 1437 0
Ethics approval number [3] 1437 0
Ethics committee name [4] 1438 0
Adelaide
Ethics committee address [4] 1438 0
Ethics committee country [4] 1438 0
Australia
Date submitted for ethics approval [4] 1438 0
Approval date [4] 1438 0
Ethics approval number [4] 1438 0
Ethics committee name [5] 1439 0
Perth
Ethics committee address [5] 1439 0
Ethics committee country [5] 1439 0
Australia
Date submitted for ethics approval [5] 1439 0
Approval date [5] 1439 0
Ethics approval number [5] 1439 0
Ethics committee name [6] 1440 0
Brisbane/Gold Coast
Ethics committee address [6] 1440 0
Ethics committee country [6] 1440 0
Australia
Date submitted for ethics approval [6] 1440 0
Approval date [6] 1440 0
Ethics approval number [6] 1440 0
Ethics committee name [7] 1441 0
Sydney
Ethics committee address [7] 1441 0
Ethics committee country [7] 1441 0
Australia
Date submitted for ethics approval [7] 1441 0
Approval date [7] 1441 0
Ethics approval number [7] 1441 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35606 0
Address 35606 0
Country 35606 0
Phone 35606 0
Fax 35606 0
Email 35606 0
Contact person for public queries
Name 9497 0
Dr Janet Rowan
Address 9497 0
National Women's Health
Private Bag 92024
Auckland 1003
Country 9497 0
New Zealand
Phone 9497 0
+ 64 9 6389909
Fax 9497 0
+ 64 9 3074918
Email 9497 0
[email protected]
Contact person for scientific queries
Name 425 0
Dr Janet Rowan
Address 425 0
National Women's Health
Private bag 92024
Auckland 1003
Country 425 0
New Zealand
Phone 425 0
+ 64 9 6389909
Fax 425 0
+64 9 307 4918
Email 425 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.