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Trial registered on ANZCTR


Registration number
ACTRN12616000924459
Ethics application status
Approved
Date submitted
23/06/2016
Date registered
12/07/2016
Date last updated
28/09/2022
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Treatment Of BOoking Gestational diabetes Mellitus Study: Evaluating the impact on obstetric outcomes of immediate versus delayed care for gestational diabetes diagnosed at booking.
Scientific title
Evaluating the impact on obstetric outcomes of immediate versus delayed care for gestational diabetes diagnosed at booking.
Secondary ID [1] 289345 0
Nil
Universal Trial Number (UTN)
U1111-1183-8410
Trial acronym
ToBOGM
Linked study record
Linked to Pilot RCT ACTRN12615000974505

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes 298971 0
Condition category
Condition code
Metabolic and Endocrine 299035 299035 0 0
Diabetes
Reproductive Health and Childbirth 299036 299036 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1-delayed GDM care until 24-28 weeks gestation if the repeat oral glucose tolerance test at that time still confirms GDM

2-GDM care involves standard management through the local diabetes service: this is identical to local GDM management in all respects including 1x2 hour education session, at least one dietetic session, take home information leaflets reflecting the education session content, food diary, self management including blood glucose monitoring, healthy eating and physical activity, regular clinic attendance with review of blood glucose monitoring and weight, standard obstetric management, pharmacological treatment as directed by the diabetes service staff.

3-attendance at clinic and associated education sessions and therapy will be recorded
Intervention code [1] 294937 0
Treatment: Other
Comparator / control treatment
Standard care from booking (<20 weeks gestation)

GDM care involves standard management through the local diabetes service: this is identical to local GDM management in all respects including 1x2 hour education session, at least one dietetic session, take home information leaflets reflecting the education session content, food diary, self management including blood glucose monitoring, healthy eating and physical activity, regular clinic attendance with review of blood glucose monitoring and weight, standard obstetric management, pharmacological treatment as directed by the diabetes service staff.
Control group
Active

Outcomes
Primary outcome [1] 298499 0
Primary pregnancy outcomes: Composite of, respiratory distress (defined as need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or intermittent positive-pressure ventilation during the first 24 hours after delivery), need for phototherapy, birth trauma using IADPSG criteria, pre-term birth (<37 weeks gestation), stillbirth/death, shoulder dystocia (vaginal cephalic delivery that requires additional obstetric manoeuvres to deliver the fetus after the head has delivered and gentle traction has failed) and birthweight greather than or equal to 4.5kgs.
Timepoint [1] 298499 0
Birth
Primary outcome [2] 298500 0
Primary maternal outcome: Incidence of hypertension in pregnancy (composite of pre-eclampsia/eclampsia/gestational hypertension).
This will be collected from the notes
Timepoint [2] 298500 0
Collected any time between 34 weeks gestation and birth
Primary outcome [3] 298516 0
Primary neonatal outcome: Fetal lean body mass measured by the Catalano equation.
Derived from neonatal anthropometric measurements: ie birthweight-fat mass, where fat mass=0.54657+ 0.39055 (birthweight kg) + 0.0453 (flank skinfold mm)– 0.03237 (length cm).
Timepoint [3] 298516 0
Birth
Secondary outcome [1] 324424 0
Neonatal fat mass from Catalano equation. Derived from neonatal anthropometric measurements: ie birthweight-fat mass, where fat mass= 0.54657+0.39055 (birthweight kg) + 0.0453 (flank skinfold mm)– 0.03237 (length cm)
Timepoint [1] 324424 0
Birth
Secondary outcome [2] 324425 0
Ethnicity adjusted customised centile for birth weight (large and small), derived from data from notes.
Timepoint [2] 324425 0
Birth
Secondary outcome [3] 324426 0
Neonate mean upper arm circumference, measured within 72 hours postnatal.
Timepoint [3] 324426 0
Within 72 hours post natal
Secondary outcome [4] 324427 0
Neonate severe hypoglycaemia (heelprick glucose <1.6mmol/l neonate), derived from notes.
Timepoint [4] 324427 0
At any point up to 72 hours after birth
Secondary outcome [5] 324428 0
Neonatal intensive care unit bed days, derived from notes.
Timepoint [5] 324428 0
Collected at any point up to 28 days after birth
Secondary outcome [6] 324429 0
Sum of neonatal callipers, measured using callipers.
Timepoint [6] 324429 0
Birth-72 hours postnatal
Secondary outcome [7] 324430 0
Maternal gestational weight gain, measured using seca scales.
Timepoint [7] 324430 0
End point is 36-38 weeks gestation. Baseline measure is from initial weight measurement on entry into the study.
Secondary outcome [8] 324431 0
Caesarean section, from notes.
Timepoint [8] 324431 0
Birth
Secondary outcome [9] 324432 0
Induction of labour, from notes.
Timepoint [9] 324432 0
Birth
Secondary outcome [10] 324433 0
Maternal hypoglycaemia, data collected from various sources including patient notes and meter downloads.
Timepoint [10] 324433 0
Birth
Secondary outcome [11] 324434 0
Perineal trauma, from notes.
Timepoint [11] 324434 0
Birth
Secondary outcome [12] 324435 0
Never breastfed, determined by bespoke study questionnaire.
Timepoint [12] 324435 0
Up to 12 weeks postnatal, completed on a single occasion within this timeframe.
Secondary outcome [13] 324436 0
Quality of Life (EQ5D)
Timepoint [13] 324436 0
28 weeks gestation, 6-12 weeks postnatal
Secondary outcome [14] 346338 0
Birthweight, from notes
Timepoint [14] 346338 0
Birth
Secondary outcome [15] 346339 0
1-2 hour heelprick glucose less than or equal to 2.2mmol/l.
Timepoint [15] 346339 0
Within 1-2 hours from birth

Eligibility
Key inclusion criteria
All pregnant women (aged greater than or equal to 18 years) with a singleton pregnancy between 4 and 19+6 weeks’ gestation, with a risk factor for GDM warranting an OGTT according to ADIPS/local guidelines, and giving signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Existing diabetes, inability to give consent, twins or triplets (or more), major active medical disorders (eg psychiatric disease requiring antipsychotic medication, but excluding chronic hypertension), women without a GDM risk factor, women greater than or equal to 20 weeks gestation, women who have already attended for an OGTT.

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)
For women to be randomised, the Central Study Coordinating team member will receive pathology results and enter these in the bespoke TOBOGM Randomiser.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation numbers will be allocated, independently, stratified by site, to one of the 2 intervention groups, using an electronic randomiser for 2 strata, based on 24-28 week OGTT criteria:
*lower risk glucose values (fasting 5.1-5.2 mmol/l or 1 hour 10.0-10.5 mmol/l or 2 hour 8.5-8.9 mmol/l) and
*higher risk glucose values (fasting 5.3-6.9 mmol/l or 1 hour greater than or equal to 10.6 mmol/l or 2 hour 9.0-11.0 mmol/l).


Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be by intention to treat with a per protocol sensitivity analysis. Data analysis will involve computations of Fisher’s exact tests (for dichotomous outcome measures), Chi-square tests (for categorical data with greater than or equal to 2 levels) and ANOVA (for continuous measures). Data will be described using 95% confidence intervals. A Statistical Analysis Plan will be drawn up to include a priori protocols for withdrawal, distributional transformations, outliers, methods for handling drop outs, any model assumptions including incorporation of covariates into analyses and handling of multiple comparisons.
Power calculations are 2 tailed, alpha 0.05, power 0.8, 1:1 case:control. TOBOGM is powered to detect a 6% difference between the treated and untreated ‘Booking GDM’ groups. This is because the trial is not a test of treatment vs no treatment of GDM, but of treatment <20 weeks vs deferral to 24-28 weeks gestation when women will be treated if GDM is then found. It is therefore proposed to use the difference between the metabolic composite for treated GDM women compared to normal control: 10% vs 4% hypoglycaemia/hyperbilirubinaemia.
There are three primary outcomes (PO1, PO2, and PO3). The study a priori significance level (alpha) is set at 0.05, and for the primary outcome analyses, we apply a gatekeeping testing strategy to assist in avoiding Type 1 errors. Specifically, if PO1 has p<0.05, then PO2 will be examined; next, if PO2 has p<0.05, then PO3 will be examined. This gatekeeper approach to the primary outcome was deemed as the most suitable method as it enables a clear focus on major adverse pregnancy outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/12/2016
Actual
17/05/2017
Date of last participant enrolment
Anticipated
31/05/2022
Actual
31/03/2022
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
800
Accrual to date
Final
802
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,WA,VIC
Recruitment hospital [1] 5887 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 5888 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 5889 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [4] 5890 0
The Canberra Hospital - Garran
Recruitment hospital [5] 5891 0
Westmead Hospital - Westmead
Recruitment hospital [6] 5892 0
Blacktown Hospital - Blacktown
Recruitment hospital [7] 5893 0
Nepean Hospital - Kingswood
Recruitment hospital [8] 5894 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [9] 5895 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [10] 5896 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [11] 5897 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [12] 13544 0
Fairfield Hospital - Prairiewood
Recruitment hospital [13] 13545 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [14] 21004 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 13334 0
2560 - Campbelltown
Recruitment postcode(s) [2] 13335 0
2170 - Liverpool
Recruitment postcode(s) [3] 13336 0
2200 - Bankstown
Recruitment postcode(s) [4] 13337 0
2605 - Garran
Recruitment postcode(s) [5] 13338 0
2145 - Westmead
Recruitment postcode(s) [6] 13339 0
2148 - Blacktown
Recruitment postcode(s) [7] 13340 0
2747 - Kingswood
Recruitment postcode(s) [8] 13341 0
3168 - Clayton
Recruitment postcode(s) [9] 13342 0
5006 - North Adelaide
Recruitment postcode(s) [10] 13343 0
5042 - Bedford Park
Recruitment postcode(s) [11] 13344 0
5112 - Elizabeth Vale
Recruitment postcode(s) [12] 26167 0
2176 - Prairiewood
Recruitment postcode(s) [13] 26168 0
2050 - Camperdown
Recruitment postcode(s) [14] 35837 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 293737 0
Government body
Name [1] 293737 0
National Health and Medical Research Council
Country [1] 293737 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797 Penrith NSW 2751 Australia
Country
Australia
Secondary sponsor category [1] 292566 0
None
Name [1] 292566 0
Address [1] 292566 0
Country [1] 292566 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295171 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 295171 0
Locked Bag 7103, Liverpool BC, NSW 1871
Ethics committee country [1] 295171 0
Australia
Date submitted for ethics approval [1] 295171 0
20/11/2015
Approval date [1] 295171 0
26/04/2016
Ethics approval number [1] 295171 0
HREC/15/LPOOL/551

Summary
Brief summary
Identifying and treating women early in pregnancy with significant hyperglycaemia at glucose values on oral glucose tolerance testing (OGTT), characterised as Diabetes in Pregnancy (DIP), is important as it improves maternal and fetal outcomes. Similarly, there is good evidence from randomised controlled trials (RCTs) that identifying women with lesser degrees of hyperglycaemia on OGTT and characterised as Gestational Diabetes (GDM) at the end of the second trimester of pregnancy, also improves such outcomes. There is, however, currently no randomised controlled trial (RCT) evidence that using the same criteria to diagnose and treat women for GDM prior to 24-28 weeks gestation, benefits either babies or their mothers, while there is potential for harm through fetal undernutrition, inappropriately medicalising some pregnancies, and increasing overall clinical workload. ToBOGM is a multicentre RCT comparing immediate referral for treatment for those women with ‘booking GDM’ on OGTT vs treating such women as normal and awaiting the results of a repeat OGTT at 24-28 weeks, proceeding to treatment only if GDM is diagnosed at that stage. TOBOGM has been through peer review and is to be funded by the National Health and Medical Research Council (NHMRC).
Trial website
Trial related presentations / publications
Public notes
Links to Pilot RCT
ACTRN: ACTRN12615000974505

Contacts
Principal investigator
Name 66338 0
Prof David Simmons
Address 66338 0
Western Sydney University, Macarthur Clinical School, Campbelltown
Mailing Address: Locked Bag 1797 Penrith NSW 2751 Australia
Country 66338 0
Australia
Phone 66338 0
+61437961795
Fax 66338 0
Email 66338 0
[email protected]
Contact person for public queries
Name 66339 0
Claudia Bishop
Address 66339 0
Western Sydney University, Macarthur Clinical School, Campbelltown
Mailing Address: Locked Bag 1797 Penrith NSW 2751 Australia
Country 66339 0
Australia
Phone 66339 0
+61246344593
Fax 66339 0
Email 66339 0
[email protected]
Contact person for scientific queries
Name 66340 0
David Simmons
Address 66340 0
Western Sydney University, Macarthur Clinical School, Campbelltown
Mailing Address: Locked Bag 1797 Penrith NSW 2751 Australia
Country 66340 0
Australia
Phone 66340 0
+61246344593
Fax 66340 0
Email 66340 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not planned at this timepoint.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17201Statistical analysis plan    370820-(Uploaded-27-09-2022-10-42-00)-Study-related document.pdf



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 AIEarly gestational diabetes screening in obese women: a randomized controlled trial2020https://doi.org/10.1016/j.ajog.2019.12.021
EmbaseTreatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy.2023https://dx.doi.org/10.1056/NEJMoa2214956
Dimensions AIGremlin-1 in pregnancy and postpartum: relation to the fatty liver index, markers of bone health, glucose metabolism and gestational diabetes mellitus status2023https://doi.org/10.1007/s00592-023-02151-7
N.B. These documents automatically identified may not have been verified by the study sponsor.