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Trial registered on ANZCTR


Registration number
ACTRN12615000282583
Ethics application status
Approved
Date submitted
5/03/2015
Date registered
25/03/2015
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Date results information initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimal glycaemic targets for women with gestational diabetes: the randomised trial - TARGET
Scientific title
To assess if tighter targets for glycaemic control in women with gestational diabetes compared with less intense targets reduce the risk of the infant being born large for gestational age.
Secondary ID [1] 283678 0
Nil
Universal Trial Number (UTN)
Trial acronym
TARGET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus
290637 0
Condition category
Condition code
Reproductive Health and Childbirth 291023 291023 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 294774 294774 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tight glycaemic targets for women with gestational diabetes initially and then fasting plasma glucose Less-Than or Equal To 5.0mmol/L; 1 hour postprandial Less-Than or Equal To 7.4mmol/L; 2 hour postprandial Less-Than or Equal To 6.7mmol/L.
These targets will be used by the responsible clinician for glycaemic control following diagnosis of gestational diabetes until the birth of the baby.
Intervention code [1] 288377 0
Treatment: Other
Comparator / control treatment
Less tight glycaemic targets for glycaemic control in women with GDM (FPG Less-Than 5.5mmol/L; 1 hour postprandial Less-Than 8.0mmol/L; 2 hour postprandial Less-Than 7.0mmol/L).
These targets will be used by the responsible clinician for glycaemic control following diagnosis of gestational diabetes until the birth of the baby.
Control group
Active

Outcomes
Primary outcome [1] 291010 0
Large for gestational age infant (defined as birth weight >90th centile using customised charts)
Timepoint [1] 291010 0
At birth
Secondary outcome [1] 305821 0
For the woman: pre-eclampsia assessed from patient medical records
Timepoint [1] 305821 0
Up to the time of hospital discharge after birth
Secondary outcome [2] 305822 0
For the woman: induction of labour assessed from patient medical records
Timepoint [2] 305822 0
At onset of labour
Secondary outcome [3] 305823 0
For the woman: mode of birth assessed from patient medical records
Timepoint [3] 305823 0
At time of birth
Secondary outcome [4] 313158 0
For the woman; gestational weight gain assessed from patient medical records
Timepoint [4] 313158 0
Up to time of labour
Secondary outcome [5] 313408 0
For the woman: maternal hypoglycaemia assessed by glucometer readings downloaded by research staff
Timepoint [5] 313408 0
Up to the time of hospital discharge after birth
Secondary outcome [6] 313409 0
For the woman: proportion of glucose values within target at 36 weeks assessed by glucometer readings downloaded by research staff
Timepoint [6] 313409 0
After birth
Secondary outcome [7] 313410 0
For the woman: length of postnatal stay assessed from patient medical records
Timepoint [7] 313410 0
Up to the time of hospital discharge after birth
Secondary outcome [8] 313411 0
For the woman: breastfeeding assessed from patient medical records
Timepoint [8] 313411 0
Up to the time of hospital discharge after birth
Secondary outcome [9] 313412 0
For the woman: psychological outcomes assessed by standard, validated questionnaires as follows: quality of life (Ware et al. Medical Care 1992;30(6):473-83). This questionnaire has not been specifically designed for this study.
Timepoint [9] 313412 0
Up to 36 weeks gestation
Secondary outcome [10] 313413 0
For the infant: a composite of serious health outcomes (perinatal death, birth trauma, nerve palsy, bone fracture, shoulder dystocia) assessed from patient medical records
Timepoint [10] 313413 0
After birth
Secondary outcome [11] 313414 0
For the infant: gestational age at birth assessed from patient medical records
Timepoint [11] 313414 0
At birth
Secondary outcome [12] 313415 0
For the infant: birth weight assessed from patient medical records
Timepoint [12] 313415 0
At birth
Secondary outcome [13] 313443 0
For the infant: macrosomia assessed from patient medical records
Timepoint [13] 313443 0
Up to the time of hospital discharge after birth
Secondary outcome [14] 313444 0
For the infant: SGA (small gestational age) assessed from patient medical records
Timepoint [14] 313444 0
At birth
Secondary outcome [15] 313445 0
For the infant: fat mass assessed by skinfold measurement taken by trained research staff
Timepoint [15] 313445 0
Up to the time of hospital discharge after birth
Secondary outcome [16] 313446 0
For the infant: respiratory support assessed from patient medical records
Timepoint [16] 313446 0
Up to the time of hospital discharge after birth
Secondary outcome [17] 313447 0
For the infant: hypoglycaemia requiring treatment (defined as blood glucose <2.6 mmol/L)
Timepoint [17] 313447 0
Up to the time of hospital discharge after birth
Secondary outcome [18] 313448 0
For the infant: hyperbilirubinaemia requiring phototherapy assessed from patient medical records
Timepoint [18] 313448 0
Up to the time of hospital discharge after birth
Secondary outcome [19] 313449 0
For the infant: neonatal intensive care unit admission assessed from patient medical records
Timepoint [19] 313449 0
Up to the time of hospital discharge after birth
Secondary outcome [20] 313450 0
For the infant: length of postnatal stay assessed from patient medical records
Timepoint [20] 313450 0
Up to the time of hospital discharge after birth
Secondary outcome [21] 313983 0
For the woman: psychological outcomes assessed by standard, validated questionnaires as follows: anxiety (Marteau et al. British Journal of Clinical Psychology 1992;31(Pt3):301-6). This questionnaire has not been specifically designed for this study.
Timepoint [21] 313983 0
Up to 36 weeks gestation
Secondary outcome [22] 313984 0
For the woman: psychological outcomes assessed by standard, validated questionnaires as follows: depression (Cox et al. British Journal of Psychiatry 1987;150:782-6). This questionnaire has not been specifically designed for this study.
Timepoint [22] 313984 0
Up to 36 weeks gestation

Eligibility
Key inclusion criteria
Hospital providing care for women with gestational diabetes diagnosed at 24 weeks gestation or later.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women where the fetus has a major anomaly.

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)
Timing of allocation to tighter targets concealed from participating sites. Hospitals will be randomised, using a stepped-wedge design to the timing of the control and intervention periods by the trial statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Hospitals will be randomised to the timing of the control and intervention periods by the trial statistician using a computer generated random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A multicentre, stepped-wedge, cluster, randomised trial.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A total sample size of 1080 participants from 10 hospitals, with on average 27 women recruited per time period in each hospital over study periods of four month (T1-T4), will provide 90% power at 5% level of significance (two-sided) to detect a treatment difference of 6% in the proportion of LGA babies, from 13% using the current target to 7% using the tighter targets, assuming an intra-cluster correlation co-efficient of 0.05.
Baseline characteristics of all randomised women will be summarized descriptively by the two time periods, control and intervention period, to assess comparability of groups. Data points in the control section wedge - Less Tight Target Period -will be compared with data points in the intervention section -Tighter Target Period - to assess the effectiveness of the intervention.
Treatment evaluations will follow the intention-to-treat principle. Imputation method will be applied to the primary outcome with any missing data. Statistical tests will be two-sided and maintained at 5% level of significance. Generalized linear mixed models will be used to evaluate the main treatment effect, with a random effect for hospital group and fixed effects for the intervention implementation and the study time period.
Secondary exploratory analyses will consider baseline covariates that show evidence of imbalance between study groups and are related to the outcome of interest. The risk estimates and 95% CIs will be reported using log binomial regression for binary outcomes. Continuous outcomes will be analysed using linear regression.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5660 0
New Zealand
State/province [1] 5660 0

Funding & Sponsors
Funding source category [1] 288366 0
Government body
Name [1] 288366 0
Health Research Council of New Zealand
Address [1] 288366 0
PO Box 5541
Wellesley Street
Auckland
1141
Country [1] 288366 0
New Zealand
Primary sponsor type
University
Name
University of Auckland, Research Office
Address
Faculty of Medical and Health Sciences
The Universiy of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 287072 0
None
Name [1] 287072 0
Address [1] 287072 0
Country [1] 287072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290244 0
Health & Disability Ethics Committee (HDEC)
Ethics committee address [1] 290244 0
Ministry of Health
C/-MEDSAFE
Level 6
Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 290244 0
New Zealand
Date submitted for ethics approval [1] 290244 0
Approval date [1] 290244 0
23/10/2014
Ethics approval number [1] 290244 0
14/NTA/163

Summary
Brief summary
Gestational diabetes (GDM) is a significant health problem affecting one in every 12 pregnant women or over 5,200 women in New Zealand annually. GDM has a major, negative impact on maternal and perinatal health with lifelong consequences. It is unclear what intensity of glycaemic control during GDM treatment is best for mother and infant.
The TARGET randomised Trial will evaluate the implementation of tighter treatment targets for blood sugar control compared with less stringent targets in women with GDM. We will compare the risk of the infant being born large for gestational age, which is strongly associated with significant early life and later health problems. Other relevant outcomes will be assessed. This trial will allow for the sequential implementation of the new, nationally recommended tighter treatment targets for women with GDM and, establish if there are true benefits, without harm, to tighter treatment targets.
Trial website
http://www.liggins.auckland.ac.nz/en/for/thecommunity/target-study.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44670 0
Prof Caroline Crowther
Address 44670 0
The Liggins Institute
Private Bag 92019
Auckland
1142
Country 44670 0
New Zealand
Phone 44670 0
+64 9 923 6011
Fax 44670 0
Email 44670 0
c.crowther@auckland.ac.nz
Contact person for public queries
Name 44671 0
Mrs Debbie Samuel
Address 44671 0
The Liggins Institute
Private Bag 92019
Auckland
1142
Country 44671 0
New Zealand
Phone 44671 0
+64 9 923 1356
Fax 44671 0
Email 44671 0
d.samuel@auckland.ac.nz
Contact person for scientific queries
Name 44672 0
Prof Caroline Crowther
Address 44672 0
The Liggins Institute
Private Bag 92019
Auckland
1142
Country 44672 0
New Zealand
Phone 44672 0
+64 9 923 6011
Fax 44672 0
Email 44672 0
c.crowther@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary