ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

Treatment: Other

Comparator / control treatment

Not Gestational Diabetes group: Routine obstetrics care by the atending obstetric team.

Control group

Active

Outcomes

Primary outcome [1]

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]

At birth

Primary outcome [2]

Primary outcomes among infants were a composite measure including admission to the neonatal nursery

Timepoint [2]

During neonatal period up to primary hospital discharge

Primary outcome [3]

Primary outcomes among infants were a composite measure including jaundice requiring phototherapy.

Timepoint [3]

During neonatal period up to primary hospital discharge

Primary outcome [4]

Primary clinical outcomes among the women were the need for induction of labour.

Timepoint [4]

Maternal health status was assessed 3 months post partum by means of the Medical Outcomes Study (SF-36).

Primary outcome [5]

Primary clinical outcomes among the women were the need for caesarean section.

Timepoint [5]

Maternal health status was assessed 3 months post partum by means of the Medical Outcomes Study (SF-36).

Secondary outcome [1]

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]

At birth and up to primary hospital discharge

Secondary outcome [2]

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]

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?

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]

United Kingdom

State/province [1]

N/A

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Project Grant

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and children's Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/06/1992

Ethics approval number [1]

20/92

Ethics committee name [2]

The Lyell McEwin Health Service

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

12/93

Ethics committee name [3]

The Queen Elizabeth Hospital

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

12/93

Ethics committee name [4]

The Flinders Medical Centre

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

1995.084

Ethics committee name [5]

The Modbury Hospital

Ethics committee address [5]

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

Ethics approval number [5]

9509-135M

Ethics committee name [6]

Royal North Shore Hospital

Ethics committee address [6]

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

Ethics approval number [6]

Ethics committee name [7]

St George Hospital

Ethics committee address [7]

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

Approval date [7]

Ethics approval number [7]

Ethics committee name [8]

Campbeltown Hospital

Ethics committee address [8]

Ethics committee country [8]

Australia

Date submitted for ethics approval [8]

Approval date [8]

Ethics approval number [8]

Ethics committee name [9]

Blacktown Hospital

Ethics committee address [9]

Ethics committee country [9]

Australia

Date submitted for ethics approval [9]

Approval date [9]

Ethics approval number [9]

Ethics committee name [10]

The Nambour Hospital

Ethics committee address [10]

Ethics committee country [10]

Australia

Date submitted for ethics approval [10]

Approval date [10]

Ethics approval number [10]

95/02

Ethics committee name [11]

Caboolture Hospital

Ethics committee address [11]

Ethics committee country [11]

Australia

Date submitted for ethics approval [11]

Approval date [11]

Ethics approval number [11]

Ethics committee name [12]

The Townsville Hospital

Ethics committee address [12]

Ethics committee country [12]

Australia

Date submitted for ethics approval [12]

Approval date [12]

Ethics approval number [12]

Ethics committee name [13]

Toowoomba Base Hospital

Ethics committee address [13]

Ethics committee country [13]

Australia

Date submitted for ethics approval [13]

Approval date [13]

Ethics approval number [13]

Ethics committee name [14]

Hervey Bay Hospital

Ethics committee address [14]

Ethics committee country [14]

Australia

Date submitted for ethics approval [14]

Approval date [14]

Ethics approval number [14]

Ethics committee name [15]

General Infirmary Leeds

Ethics committee address [15]

Ethics committee country [15]

United Kingdom

Date submitted for ethics approval [15]

Approval date [15]

Ethics approval number [15]

Ethics committee name [16]

Hammersmith Hospital London

Ethics committee address [16]

Ethics committee country [16]

United Kingdom

Date submitted for ethics approval [16]

Approval date [16]

Ethics approval number [16]

Ethics committee name [17]

Northern General Hospital Sheffield

Ethics committee address [17]

Ethics committee country [17]

United Kingdom

Date submitted for ethics approval [17]

Approval date [17]

Ethics approval number [17]

Ethics committee name [18]

Bradford Royal Infirmary Maternity Unit

Ethics committee address [18]

Ethics committee country [18]

United Kingdom

Date submitted for ethics approval [18]

Approval date [18]

Ethics approval number [18]

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]

/AnzctrAttachments/1447-Crowther et al. NEJM 2005 ACHOIS Main Trial.pdf

Attachments [2]

/AnzctrAttachments/1447-ATHUKORALA_et_al-2007-Australian_and_New_Zealand_Journal_of_Obstetrics_and_Gynaecology.pdf

Attachments [3]

/AnzctrAttachments/1447-Pirc et al BMC Pediatrics 2007.pdf

Attachments [4]

/AnzctrAttachments/1447-Moss JR et all BMC Pregnancy and Childbirth 2007.pdf

Contacts

Principal investigator

Name

Prof Caroline Crowther

Address

University Obstetrics & Gynaecology
Women's and Children's Hospital
Level 1, Queen Victoria Building
72 King William Road
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 7619

Fax

+61 8 8161 7652

[email protected]

Contact person for public queries

Name

Caroline Crowther

Address

University Obstetrics & Gynaecology
Women's and Children's Hospital
Level 1, Queen Victoria Building
72 King William Road
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 7619

Fax

[email protected]

Contact person for scientific queries

Name

Caroline Crowther

Address

University Obstetrics & Gynaecology
Women's and Children's Hospital
Level 1 Queen Victoria Building
72 King William Road
North Adelaide SA 5006

Country

Australia

Phone

08 8161 7647

Fax

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Costs and consequences of treatment for mild gestational diabetes mellitus – evaluation from the ACHOIS randomised trial	2007	https://doi.org/10.1186/1471-2393-7-27

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically