Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000174482
Ethics application status
Approved
Date submitted
12/10/2006
Date registered
19/03/2007
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The IDEAL Randomised Controlled Trial
Scientific title
A randomised study to investigate the effects of dietary and lifestyle advice for pregnant women with borderline gestational glucose diabetes to reduce the risk of large for gestational age (LGA) infants, infant morbidity and maternal physical morbidity.
Secondary ID [1] 280419 0
Please leave blank there is no secondary ID for this trial
Universal Trial Number (UTN)
Trial acronym
IDEAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnant women with borderline gestational diabetes 1689 0
Condition category
Condition code
Reproductive Health and Childbirth 286637 286637 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group: women in the 'Intervention Group' will be advised that their oral glucose tolerance test (OGTT) results are normal but that they have borderline glucose intolerance. These women will receive a single face-to-face session of approximately 45 minutes duration providing individualised dietary and lifestyle advice from a qualified dietician, based on published recommendations of the Dieticians Association of Australia, that are culturally appropriate and meet the nutritional requirements of pregnancy. The following characteristics of the mother: age, pre-pregnancy weight, activity level, current dietary intake and weight gain for the current and previous pregnancies will be considered in developing an individualised diet and exercise plan. Written information will be provided to the women detailing their dietary and exercise goals during pregnancy. This session with the dietician is to be scheduled as soon as possible after study enrolment (between 24 weeks and 34 weeks 6 days gestation). At each routine antenatal visit from enrolment until birth, women will have their weight recorded, blood glucose monitoring and further treatment, if appropriate. Progress with their dietary and exercise goals will be reviewed with their health professional. All other pregnancy care to be provided by the attending obstetric team according to current clinical practice in hospitals in Australia.

They will be asked to complete a questionnaire on health related quality of life at 36 weeks gestation. They will also be asked about their physical activity and dietary habits.
Intervention code [1] 1400 0
Lifestyle
Comparator / control treatment
Routine Care Group: Women in the ‘Routine Care Group’ will be advised that their oral glucose tolerance test results are normal. These women will receive routine obstetric care by the attending obstetric team. Care of women in the ‘Routine Care Group' will follow current clinical practice in hospitals in Australia.

They will be asked to complete a questionnaire on health related quality of life at 36 weeks gestation. They will also be asked about their physical activity and dietary habits.
Control group
Active

Outcomes
Primary outcome [1] 2492 0
Incidence of large for gestational age (LGA) infants defined as birthweight above the 90th centile for gestation and fetal sex on standardised birthweight charts.
Timepoint [1] 2492 0
Measured at birth
Secondary outcome [1] 4301 0
For the infant: death or serious health outcome including one or more of fetal death after trial entry; death of a liveborn infant prior to hospital discharge; severe intrauterine growth restriction (birthweight < 3rd centile for gestation and fetal sex on standardised birth weight charts); severe respiratory distress syndrome (defined as MAP >10 cmH2O and or FiO2 >= 0.80); chronic lung disease (defined as need for oxygen at 36 weeks postmenstrual age); intraventricular haemorrhage grade 3 or 4; cystic periventricular leukomalacia; retinopathy of prematurity grade 3 or 4; necrotising enterocolitis; Apgar score < 4 at 5 minutes; seizures at <24 hours age or requiring two or more drugs to control; tube feeding >=4 days; care in neonatal intensive care unit >4 days; use of ventilation for >=24 hours. These definitions of serious infant outcomes are based on the definitions for adverse outcomes used by the Australian New Zealand Neonatal Network and from those considered by experts as important measures of morbidity at or beyond term.
Timepoint [1] 4301 0
Measured up to primary hospital discharge
Secondary outcome [2] 4302 0
For the infant: other causes of infant morbidity as defined by: individual components of the composite infant outcome; neonatal jaundice requiring phototherapy; neonatal hypoglycaemia requiring treatment (defined as blood glucose < 2.5 mmol/L); shoulder dystocia; nerve palsy; bone fracture; gestational age at birth; preterm birth (less than 37 weeks gestation), Apgar score <7 at five minutes; weight, length, head circumference, small for gestational age (< 10th percentile for gestation and fetal sex on standardised birthweight charts); macrosomia (>=4 kg); need for admission to the neonatal nursery and length of stay; and need for admission to neonatal intensive care and length of stay; incidence and severity of respiratory distress syndrome, use of and length of mechanical ventilation, intraventricular haemorrhage on early cranial ultrasound, periventricular leukomalacia on later cranial ultrasound, need for oxygen therapy at 28 days or more of life, use of postnatal steroids, use of antibiotics in first 48 hours of life, proven systemic infection in first 48 hours of life, use of antibiotics after first 48 hours of life, proven systemic infection after first 48 hours of life, use of surfactant, nitric oxide for respiratory support, need for inotropic support, air leak syndrome, retinopathy of prematurity, patent ductus arteriosus requiring treatment, number of episodes of proven infection, proven necrotising enterocolitis, thrombocytopenia, neonatal encephalopathy (Sarnat Stage 1, 2 or 3).
Timepoint [2] 4302 0
Measured up to primary hospital discharge.
Secondary outcome [3] 4303 0
For the mother: serious health outcomes up to six weeks postpartum as defined by one or more of maternal death, pulmonary oedema; eclampsia; stroke; adult respiratory distress syndrome; cardiac arrest; respiratory arrest; placental abruption; haemolysis; coagulopathy; major postpartum haemorrhage; deep vein thrombosis or pulmonary embolism requiring anticoagulant therapy.
Timepoint [3] 4303 0
Measured up to 6 weeks postpartum.
Secondary outcome [4] 299625 0
Other adverse health outcomes for the woman as defined by: individual components of the composite maternal outcome; pre-eclampsia; caesarean birth; induction of labour; need for antenatal hospitalization and length of stay; antepartum haemorrhage requiring hospital admission; weight gain during pregnancy; use of antihypertensive medication; chorioamnionitis requiring antibiotics during labour; length of postnatal hospital stay; use of postnatal antibiotics; and postpartum haemorrhage (>=500mls).
Timepoint [4] 299625 0
Measured up to 6 weeks postpartum.
Secondary outcome [5] 299626 0
Maternal diet outcomes as measured by the Willett Food Frequency Questionnaire and exercise outcomes as measured y the Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH) at trial entry and 36 weeks gestation.
Timepoint [5] 299626 0
Measured at trial entry and 36 weeks gestation.

Eligibility
Key inclusion criteria
Women between 24 weeks 0 days and 34 weeks 6 days gestation with a singleton pregnancy, with a positive OGCT (venous plasma glucose >=7.8 mmol/L) and a normal 75 gram OGTT (fasting venous plasma glucose <5.5 mmol/L and a 2 hour glucose <7.8 mmol/L), who give written, informed consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with known diabetes mellitus, previously treated GDM, active chronic systemic disease (except essential hypertension and mild forms of asthma) or a multiple pregnancy.

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)
Central randomisation by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Balanced variable block permutation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/01/2008
Actual
8/01/2008
Date of last participant enrolment
Anticipated
Actual
28/09/2012
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
682
Accrual to date
Final
724
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS

Funding & Sponsors
Funding source category [1] 1935 0
Government body
Name [1] 1935 0
National Health and Medical Research Council (NHMRC)
Country [1] 1935 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital, Adelaide, SA.
Address
72 King William Road,
North Adelaide
SA , 5006
Country
Australia
Secondary sponsor category [1] 1746 0
None
Name [1] 1746 0
Nil
Address [1] 1746 0
Country [1] 1746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3606 0
Children, Youth & Women's Health Service (CYWHS) Human Research Ethics Committee (HREC)
Ethics committee address [1] 3606 0
Women's and Children's Hospital,
72 King William Road,
North Adelaide
SA , 5006
Ethics committee country [1] 3606 0
Australia
Date submitted for ethics approval [1] 3606 0
Approval date [1] 3606 0
25/09/2006
Ethics approval number [1] 3606 0
REC1860/8/09

Summary
Brief summary
Over 22,000 pregnant women in Australia each year (7.7% of pregnancies) develop Borderline Gestational Diabetes Mellitus (GDM).

The primary aim of the IDEAL Study is to assess whether dietary and lifestyle advice and treatment given to pregnant women who have borderline gestational diabetes on screening for gestational diabetes (defined as a positive oral glucose challenge screening test (OGCT) followed by a normal oral glucose tolerance test (OGTT)), reduces neonatal complications and maternal risks.

The primary hypothesis of the study is that dietary and lifestyle advice and treatment given to women who have borderline gestational diabetes on screening for gestational diabetes will reduce the incidence of large for gestational age infants defined as birthweight above the 90th centile for gestation and fetal sex on standardised birthweight charts.

If treatment of these women is effective this would reduce the burden of disease for women and their babies, with implications for improved health through childhood, adolescence and adulthood.
Trial website
http://www.adelaide.edu.au/arch/research/clinical_trials/ideal.html
Trial related presentations / publications
Preparation of initial publications underway
Public notes

Contacts
Principal investigator
Name 27627 0
Prof Caroline Crowther
Address 27627 0
Australian Research Centre for Health of Women and Babies (ARCH) Discipline of Obstetrics and Gynaecology The University of Adelaide Women's and Children's Hospital King William Road North Adelaide South Australia 5006
Country 27627 0
Australia
Phone 27627 0
+61 8 8161 7619
Fax 27627 0
Email 27627 0
caroline.crowther@adelaide.edu.au
Contact person for public queries
Name 10589 0
Ms Pat Ashwood
Address 10589 0
Australian Research Centre for Health of Women and Babies (ARCH)
Discipline of Obstetrics and Gynaecology
The University of Adelaide
Women's and Children's Hospital
King William Road
North Adelaide
South Australia 5006
Country 10589 0
Australia
Phone 10589 0
+61 8 8161 7767
Fax 10589 0
+61 8 8161 7652
Email 10589 0
pat.ashwood@adelaide.edu.au
Contact person for scientific queries
Name 1517 0
Prof Caroline Crowther
Address 1517 0
University of Adelaide
Obstetrics & Gynaecology
Women's and Children's Hospital
Level 1
Queen Victoria Building
72 King William Road
North Adelaide SA 5006
Country 1517 0
Australia
Phone 1517 0
+61 8 8161 7647
Fax 1517 0
+61 8 8161 7652
Email 1517 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
No additional documents have been identified.