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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

4/07/2022

Date data sharing statement 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]

Nil

Universal Trial Number (UTN)

Trial acronym

TARGET

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gestational Diabetes Mellitus

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Metabolic and Endocrine

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]

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]

Large for gestational age infant (defined as birth weight >90th centile using customised charts)

Timepoint [1]

At birth

Secondary outcome [1]

For the woman: pre-eclampsia assessed from patient medical records

Timepoint [1]

Up to the time of hospital discharge after birth

Secondary outcome [2]

For the woman: induction of labour assessed from patient medical records

Timepoint [2]

At onset of labour

Secondary outcome [3]

For the woman: mode of birth assessed from patient medical records

Timepoint [3]

At time of birth

Secondary outcome [4]

For the woman; gestational weight gain assessed from patient medical records

Timepoint [4]

Up to time of labour

Secondary outcome [5]

For the woman: maternal hypoglycaemia assessed by glucometer readings downloaded by research staff

Timepoint [5]

Up to the time of hospital discharge after birth

Secondary outcome [6]

For the woman: proportion of glucose values within target at 36 weeks assessed by glucometer readings downloaded by research staff

Timepoint [6]

After birth

Secondary outcome [7]

For the woman: length of postnatal stay assessed from patient medical records

Timepoint [7]

Up to the time of hospital discharge after birth

Secondary outcome [8]

For the woman: breastfeeding assessed from patient medical records

Timepoint [8]

Up to the time of hospital discharge after birth

Secondary outcome [9]

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]

Up to 36 weeks gestation

Secondary outcome [10]

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]

After birth

Secondary outcome [11]

For the infant: gestational age at birth assessed from patient medical records

Timepoint [11]

At birth

Secondary outcome [12]

For the infant: birth weight assessed from patient medical records

Timepoint [12]

At birth

Secondary outcome [13]

For the infant: macrosomia assessed from patient medical records

Timepoint [13]

Up to the time of hospital discharge after birth

Secondary outcome [14]

For the infant: SGA (small gestational age) assessed from patient medical records

Timepoint [14]

At birth

Secondary outcome [15]

For the infant: fat mass assessed by skinfold measurement taken by trained research staff

Timepoint [15]

Up to the time of hospital discharge after birth

Secondary outcome [16]

For the infant: respiratory support assessed from patient medical records

Timepoint [16]

Up to the time of hospital discharge after birth

Secondary outcome [17]

For the infant: hypoglycaemia requiring treatment (defined as blood glucose <2.6 mmol/L)

Timepoint [17]

Up to the time of hospital discharge after birth

Secondary outcome [18]

For the infant: hyperbilirubinaemia requiring phototherapy assessed from patient medical records

Timepoint [18]

Up to the time of hospital discharge after birth

Secondary outcome [19]

For the infant: neonatal intensive care unit admission assessed from patient medical records

Timepoint [19]

Up to the time of hospital discharge after birth

Secondary outcome [20]

For the infant: length of postnatal stay assessed from patient medical records

Timepoint [20]

Up to the time of hospital discharge after birth

Secondary outcome [21]

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]

Up to 36 weeks gestation

Secondary outcome [22]

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]

Up to 36 weeks gestation

Eligibility

Key inclusion criteria

Hospital providing care for women with gestational diabetes diagnosed between 22 weeks' gestation and 34 weeks' gestation.

Minimum age

No limit

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

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

1/04/2015

Actual

29/05/2015

Date of last participant enrolment

Anticipated

1/06/2019

Actual

7/11/2017

Date of last data collection

Anticipated

Actual

6/08/2018

Sample size

Target

1080

Accrual to date

Final

1100

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

PO Box 5541
Wellesley Street
Auckland
1141

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health & Disability Ethics Committee (HDEC)

Ethics committee address [1]

Ministry of Health
C/-MEDSAFE
Level 6
Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

23/10/2014

Ethics approval number [1]

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

Attachments [1]

/AnzctrAttachments/365403-3705674 - TARGET HDEC Letter 14NTA163.pdf

Contacts

Principal investigator

Name

Prof Caroline Crowther

Address

The Liggins Institute
Private Bag 92019
Auckland
1142

Country

New Zealand

Phone

+64 9 923 6011

Fax

[email protected]

Contact person for public queries

Name

Debbie Samuel

Address

The Liggins Institute
Private Bag 92019
Auckland
1142

Country

New Zealand

Phone

+64 9 923 1356

Fax

[email protected]

Contact person for scientific queries

Name

Caroline Crowther

Address

The Liggins Institute
Private Bag 92019
Auckland
1142

Country

New Zealand

Phone

+64 9 923 6011

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

A de-identified data set and a data dictionary used in the analyses.

When will data be available (start and end dates)?

Data will be available six months after publication of the main trial paper.

Available to whom?

Data will be shared with researchers who provide a methodologically sound proposal and have appropriate ethical approval, where necessary, to achieve the research aims in the approved proposal.

Available for what types of analyses?

For individual participant data meta-analysis, aggregate meta-analysis, analyses for methodologically sound research that has ethical approval.

How or where can data be obtained?

Maternal and Perinatal Research Hub at the Liggins Institute, University of Auckland ([email protected]).

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
Embase	Views and Experiences of New Zealand Women with Gestational Diabetes in Achieving Glycaemic Control Targets: The Views Study.	2017	https://dx.doi.org/10.1155/2017/2190812
Embase	Enablers and barriers for women with gestational diabetes mellitus to achieve optimal glycaemic control: A qualitative study using the theoretical domains framework.	2018	https://dx.doi.org/10.1111/jpc.13882_84
Embase	How do women with gestational diabetes mellitus achieve their recommended glycaemic treatment targets? The views survey.	2018	https://dx.doi.org/10.1111/jpc.13882_236
Embase	Tight or less tight glycaemic targets for women with gestational diabetes mellitus for reducing maternal and perinatal morbidity? (TARGET): Study protocol for a stepped wedge randomised trial.	2018	https://dx.doi.org/10.1186/s12884-018-2060-2
Embase	Enabler and barrier perceptions and experiences of New Zealand key informant health professionals' before and after implementing tighter glycaemic targets for women with gestational diabetes.	2019	https://dx.doi.org/10.1111/jpc.14409_83
Embase	Sociodemographic factors associated with adherence to dietary guidelines in women with gestational diabetes: A cohort study.	2021	https://dx.doi.org/10.3390/nu13061884
Embase	Tighter or less tight glycaemic targets for women with gestational diabetes mellitus for reducing maternal and perinatal morbidity: A stepped-wedge, cluster-randomised trial.	2022	https://dx.doi.org/10.1371/journal.pmed.1004087
Embase	Do glycaemic treatment targets affect the perinatal mental health status of women with gestational diabetes? - Data from the TARGET Trial.	2023	https://dx.doi.org/10.1186/s12884-023-06190-4

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

Trial Review

Documents added manually

Documents added automatically