Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000294550
Ethics application status
Approved
Date submitted
6/07/2006
Date registered
11/07/2006
Date last updated
11/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australasian Carbohydrate Intolerance Study in Pregnancy
Scientific title
Australasian Carbohydrate Intolerance Study in Pregnancy
Secondary ID [1] 277 0
Perinatal Society of Australia and New Zealand (PSANZ) Impact Registry/Perinatal Trials Registry: PT0353
Universal Trial Number (UTN)
Trial acronym
ACHOIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women with glucose intolerance in pregnancy 1268 0
Condition category
Condition code
Reproductive Health and Childbirth 1354 1354 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Glucose Intolerance Group: Routine obstetrics care by the attending obstetric team, dietary advice, glucose monitoring and insulin therapy as needed
Study continued until recruitment was completed, final follow up was 3 months postpartum.
Intervention code [1] 1190 0
Treatment: Other
Comparator / control treatment
Not Gestational Diabetes group: Routine obstetrics care by the atending obstetric team.
Control group
Active

Outcomes
Primary outcome [1] 1845 0
Primary outcomes among infants were a composite measure including the serious perinatal complications (defined as one or more of the following: death, shoulder dystocia, bone fracture, and nerve palsy)
Timepoint [1] 1845 0
At birth
Primary outcome [2] 1846 0
Primary outcomes among infants were a composite measure including admission to the neonatal nursery
Timepoint [2] 1846 0
During neonatal period up to primary hospital discharge
Primary outcome [3] 1847 0
Primary outcomes among infants were a composite measure including jaundice requiring phototherapy.
Timepoint [3] 1847 0
During neonatal period up to primary hospital discharge
Primary outcome [4] 1848 0
Primary clinical outcomes among the women were the need for induction of labour.
Timepoint [4] 1848 0
Maternal health status was assessed 3 months post partum by means of the Medical Outcomes Study (SF-36).
Primary outcome [5] 1849 0
Primary clinical outcomes among the women were the need for caesarean section.
Timepoint [5] 1849 0
Maternal health status was assessed 3 months post partum by means of the Medical Outcomes Study (SF-36).
Secondary outcome [1] 3248 0
Secondary outcomes among the infants included components of the composite primary outcome, gestational age at birth, birth weight, and other measure of health.
Timepoint [1] 3248 0
At birth and up to primary hospital discharge
Secondary outcome [2] 3249 0
Secondary outcomes among the women included the number of prenatal visits to a health professional, the mode of birth, weight gain during pregnancy measured at initial pregnancy booking visit, at 28 weeks and last antenatal visit, the number of antenatal admissions, and the presence of absence of pregnancy-induced hypertension.
Timepoint [2] 3249 0
During pregnancy and at birth

Eligibility
Key inclusion criteria
Singleton or twin pregnancy with a positive Glucose Challenge Test (GCT) or risk factors for Gestational Diabetes Mellitus (GDM) at 16-30.0 weeks gestation and at 24-34.6 weeks gestation, an Oral Glucose Tolerance Test (OGTT) result: fasting <7.8mmol/L and 2 hour > or equal to 7.8mmol/L and < or equal to 11.0mmol/L.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously treated Glucose Intolerance in Pregnancy or Gestational Diabetes, Chronic active systemic disease (excluding essential hypertension), Diabetes, Gestational Diabetes OGTT result (fasting > or equal to 7.8mmol/L and/or 2 hr > or equal to 11.1mmol/L), Glucose Intolerance in Pregnanct detected in current pregnancy before 20 weeks.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central telephone randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/1993
Actual
2/09/1993
Date of last participant enrolment
Anticipated
Actual
30/06/2003
Date of last data collection
Anticipated
Actual
30/03/2004
Sample size
Target
1000
Accrual to date
Final
1000
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment outside Australia
Country [1] 7545 0
United Kingdom
State/province [1] 7545 0
N/A

Funding & Sponsors
Funding source category [1] 1485 0
Government body
Name [1] 1485 0
NHMRC Project Grant
Country [1] 1485 0
Australia
Primary sponsor type
Individual
Name
Prof Caroline Crowther
Address
Discipline of Obstetrics & Gynaecology, University of Adelaide
Women's & Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 1308 0
None
Name [1] 1308 0
Nil
Address [1] 1308 0
Country [1] 1308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2893 0
Women's and children's Hospital
Ethics committee address [1] 2893 0
Ethics committee country [1] 2893 0
Australia
Date submitted for ethics approval [1] 2893 0
Approval date [1] 2893 0
01/06/1992
Ethics approval number [1] 2893 0
20/92
Ethics committee name [2] 2894 0
The Lyell McEwin Health Service
Ethics committee address [2] 2894 0
Ethics committee country [2] 2894 0
Australia
Date submitted for ethics approval [2] 2894 0
Approval date [2] 2894 0
Ethics approval number [2] 2894 0
12/93
Ethics committee name [3] 2895 0
The Queen Elizabeth Hospital
Ethics committee address [3] 2895 0
Ethics committee country [3] 2895 0
Australia
Date submitted for ethics approval [3] 2895 0
Approval date [3] 2895 0
Ethics approval number [3] 2895 0
12/93
Ethics committee name [4] 2896 0
The Flinders Medical Centre
Ethics committee address [4] 2896 0
Ethics committee country [4] 2896 0
Australia
Date submitted for ethics approval [4] 2896 0
Approval date [4] 2896 0
Ethics approval number [4] 2896 0
1995.084
Ethics committee name [5] 2897 0
The Modbury Hospital
Ethics committee address [5] 2897 0
Ethics committee country [5] 2897 0
Australia
Date submitted for ethics approval [5] 2897 0
Approval date [5] 2897 0
Ethics approval number [5] 2897 0
9509-135M
Ethics committee name [6] 2898 0
Royal North Shore Hospital
Ethics committee address [6] 2898 0
Ethics committee country [6] 2898 0
Australia
Date submitted for ethics approval [6] 2898 0
Approval date [6] 2898 0
Ethics approval number [6] 2898 0
Ethics committee name [7] 2899 0
St George Hospital
Ethics committee address [7] 2899 0
Ethics committee country [7] 2899 0
Australia
Date submitted for ethics approval [7] 2899 0
Approval date [7] 2899 0
Ethics approval number [7] 2899 0
Ethics committee name [8] 2900 0
Campbeltown Hospital
Ethics committee address [8] 2900 0
Ethics committee country [8] 2900 0
Australia
Date submitted for ethics approval [8] 2900 0
Approval date [8] 2900 0
Ethics approval number [8] 2900 0
Ethics committee name [9] 2901 0
Blacktown Hospital
Ethics committee address [9] 2901 0
Ethics committee country [9] 2901 0
Australia
Date submitted for ethics approval [9] 2901 0
Approval date [9] 2901 0
Ethics approval number [9] 2901 0
Ethics committee name [10] 2902 0
The Nambour Hospital
Ethics committee address [10] 2902 0
Ethics committee country [10] 2902 0
Australia
Date submitted for ethics approval [10] 2902 0
Approval date [10] 2902 0
Ethics approval number [10] 2902 0
95/02
Ethics committee name [11] 2903 0
Caboolture Hospital
Ethics committee address [11] 2903 0
Ethics committee country [11] 2903 0
Australia
Date submitted for ethics approval [11] 2903 0
Approval date [11] 2903 0
Ethics approval number [11] 2903 0
Ethics committee name [12] 2904 0
The Townsville Hospital
Ethics committee address [12] 2904 0
Ethics committee country [12] 2904 0
Australia
Date submitted for ethics approval [12] 2904 0
Approval date [12] 2904 0
Ethics approval number [12] 2904 0
Ethics committee name [13] 2905 0
Toowoomba Base Hospital
Ethics committee address [13] 2905 0
Ethics committee country [13] 2905 0
Australia
Date submitted for ethics approval [13] 2905 0
Approval date [13] 2905 0
Ethics approval number [13] 2905 0
Ethics committee name [14] 2906 0
Hervey Bay Hospital
Ethics committee address [14] 2906 0
Ethics committee country [14] 2906 0
Australia
Date submitted for ethics approval [14] 2906 0
Approval date [14] 2906 0
Ethics approval number [14] 2906 0
Ethics committee name [15] 2907 0
General Infirmary Leeds
Ethics committee address [15] 2907 0
Ethics committee country [15] 2907 0
United Kingdom
Date submitted for ethics approval [15] 2907 0
Approval date [15] 2907 0
Ethics approval number [15] 2907 0
Ethics committee name [16] 2908 0
Hammersmith Hospital London
Ethics committee address [16] 2908 0
Ethics committee country [16] 2908 0
United Kingdom
Date submitted for ethics approval [16] 2908 0
Approval date [16] 2908 0
Ethics approval number [16] 2908 0
Ethics committee name [17] 2909 0
Northern General Hospital Sheffield
Ethics committee address [17] 2909 0
Ethics committee country [17] 2909 0
United Kingdom
Date submitted for ethics approval [17] 2909 0
Approval date [17] 2909 0
Ethics approval number [17] 2909 0
Ethics committee name [18] 2910 0
Bradford Royal Infirmary Maternity Unit
Ethics committee address [18] 2910 0
Ethics committee country [18] 2910 0
United Kingdom
Date submitted for ethics approval [18] 2910 0
Approval date [18] 2910 0
Ethics approval number [18] 2910 0

Summary
Brief summary
Gestational impaired glucose tolerance, associated with subsequent maternal non-insulin dependent diabetes, is routinely screened for during pregnancy, despite the lack of consensus as to the value of such screening and the subsequent management. Epidemiological studies suggest maternal and perinatal morbidity, often attributed to glucose intolerance in pregnancy, is more likely to be due to the effects of maternal age, maternal obesity or the knowledge of the diagnosis and the consequences of subsequent management. The aim of this multicentre study is to assess two forms of antenatal care in women with impaired glucose tolerance; routine antenatal care with 'diabetic style care'. The primary outcomes relate to important perinatal and maternal morbidity. The results will help answer the question as to whether substantial resources should be applied to the diagnosis and management of glucose intolerance in pregnancy.
This trial assesses two forms of care for treating women with glucose intolerance of pregnancy.
Trial website
Trial related presentations / publications
Effect of treatment of gestational diabetes mellitus on pregnancy outcomes.
Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group..
N Engl J Med. 2005 Jun 16;352(24):2477-86
Public notes
Attachments [1] 731 731 0 0
/AnzctrAttachments/1447-Crowther et al. NEJM 2005 ACHOIS Main Trial.pdf
Attachments [2] 732 732 0 0
/AnzctrAttachments/1447-ATHUKORALA_et_al-2007-Australian_and_New_Zealand_Journal_of_Obstetrics_and_Gynaecology.pdf
Attachments [3] 733 733 0 0
/AnzctrAttachments/1447-Pirc et al BMC Pediatrics 2007.pdf
Attachments [4] 734 734 0 0
/AnzctrAttachments/1447-Moss JR et all BMC Pregnancy and Childbirth 2007.pdf

Contacts
Principal investigator
Name 35506 0
Prof Caroline Crowther
Address 35506 0
University Obstetrics & Gynaecology
Women's and Children's Hospital
Level 1, Queen Victoria Building
72 King William Road
North Adelaide SA 5006
Country 35506 0
Australia
Phone 35506 0
+61 8 8161 7619
Fax 35506 0
+61 8 8161 7652
Email 35506 0
caroline.crowther@adelaide.edu.au
Contact person for public queries
Name 10379 0
Caroline Crowther
Address 10379 0
University Obstetrics & Gynaecology
Women's and Children's Hospital
Level 1, Queen Victoria Building
72 King William Road
North Adelaide SA 5006
Country 10379 0
Australia
Phone 10379 0
+61 8 8161 7619
Fax 10379 0
Email 10379 0
caroline.crowther@adelaide.edu.au
Contact person for scientific queries
Name 1307 0
Caroline Crowther
Address 1307 0
University Obstetrics & Gynaecology
Women's and Children's Hospital
Level 1 Queen Victoria Building
72 King William Road
North Adelaide SA 5006
Country 1307 0
Australia
Phone 1307 0
08 8161 7647
Fax 1307 0
Email 1307 0
caroline.crowther@adelaide.edu.au

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
SourceTitleYear of PublicationDOI
Dimensions AICosts and consequences of treatment for mild gestational diabetes mellitus – evaluation from the ACHOIS randomised trial2007https://doi.org/10.1186/1471-2393-7-27
N.B. These documents automatically identified may not have been verified by the study sponsor.