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Trial registered on ANZCTR


Registration number
ACTRN12615000974505
Ethics application status
Approved
Date submitted
11/08/2015
Date registered
17/09/2015
Date last updated
7/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Treatment Of BOoking Gestational diabetes Mellitus (TOBOGM) Pilot Study: Evaluating the impact on obstetric outcomes of immediate versus delayed care for gestational diabetes diagnosed at booking
Scientific title
Pilot study evaluating the impact on obstetric outcomes of immediate versus delayed care for gestational diabetes diagnosed at booking
Secondary ID [1] 287260 0
Nil
Universal Trial Number (UTN)
NIL
Trial acronym
TOBOGM Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes 295878 0
Condition category
Condition code
Metabolic and Endocrine 296131 296131 0 0
Diabetes
Reproductive Health and Childbirth 296200 296200 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1-delayed GDM care until 24-28 weeks 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] 292563 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] 295805 0
Feasibility of study as assessed by the number of eligible participants recruited and lost to follow-up

Timepoint [1] 295805 0
Birth
Primary outcome [2] 295874 0
Maternal: Composite of pre-eclampsia/PIH

This will be collected from the notes
Timepoint [2] 295874 0
Birth
Primary outcome [3] 295875 0
Neonatal: 1-Pregnancy-Composite of 1 hour heelprick glucose =<2.2 mmol/l, respiratory distress, phototherapy, birth trauma, 5 min APGAR score <7, pre-term birth (<37 weeks), miscarriage/stillbirth/death, shoulder dystocia

These will be collected from the notes
Timepoint [3] 295875 0
Birth
Secondary outcome [1] 316573 0
Neonatal body mass compartments (fat mass, lean mass)

Derived from neonatal anthropometric measurements: Fetal lean body mass measured by the Catalano equation ie birthweight-fat mass, where fat mass=0.39055 (birthweight kg) + 0.0453 (flank skinfold mm)– 0.03237 (length cm)

Catalano PM et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Inadequate weight gain in overweight and obese pregnant women: what is the effect on fetal growth? Am J Obstet Gynecol. 2014;211:137.e1-7
Timepoint [1] 316573 0
24-72 hours postnatal
Secondary outcome [2] 316773 0
Customised centile for birthweight (large and small)

Derived from data from notes
Timepoint [2] 316773 0
birth
Secondary outcome [3] 316774 0
mean upper arm circumference

measured 24-72 hours postnatal
Timepoint [3] 316774 0
24-72 hours postnatal

Secondary outcome [4] 316775 0
severe hypoglycaemia (heelprick glucose <1.6 mmol/l)

derived from notes
Timepoint [4] 316775 0
at any point up to 72 hours after birth
Secondary outcome [5] 316776 0
neonatal intensive care unit bed days

from notes
Timepoint [5] 316776 0
at any point up to 28 days after birth
Secondary outcome [6] 316777 0
sum of neonatal callipers

measured using callipers
Timepoint [6] 316777 0
24-72 hours postnatal
Secondary outcome [7] 316778 0
maternal gestational weight gain.

measured using seca scales
Timepoint [7] 316778 0
End point is 36-38 weeks gestation

Baseline measure is from initial weight measurement on entry into the study
Secondary outcome [8] 316779 0
Caesarean section

from notes
Timepoint [8] 316779 0
birth
Secondary outcome [9] 316780 0
induction of labour

from notes
Timepoint [9] 316780 0
birth
Secondary outcome [10] 316781 0
maternal hypoglycaemia

from meter downloads
Timepoint [10] 316781 0
birth
Secondary outcome [11] 316782 0
perineal trauma

from notes
Timepoint [11] 316782 0
birth
Secondary outcome [12] 316783 0
breast feeding

questionnaire designed for this study
Timepoint [12] 316783 0
6-12 weeks postnatal
Secondary outcome [13] 316784 0
Quality of life using EQ5D within questionnaires
Timepoint [13] 316784 0
28weeks gestation, 6-12 weeks postnatal

Eligibility
Key inclusion criteria
Pregnant women (aged >=18years) with a singleton pregnancy between 4 and 19+6 weeks’ gestation, attending the hospital Book in clinic, with a risk factor for GDM warranting an OGTT according to ADIPS/local guidelines. Ability to read and understand English for consent purposes.
Minimum age
18 Years
Maximum age
No limit
Gender
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), women without a GDM risk factor, women >=20 weeks gestation

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)
allocation involved contacting the holder of the allocation schedule who was “off-site”
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
electronic randomisation (SPSS)
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
All women recruited will have an OGTT
Women with GDM will be randomised to referral or 'not for referral to GDM clinic'
women without GDM will also receive the advice 'not for referral to GDM clinic'
The delayed treatment group will therefore be hidden among normal 'decoys'
All women who have not been referred to the GDM clinic will have an OGTT at 24-28 weeks
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a pilot study.

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 >2 levels) and ANOVA (for continuous measures). Data will be described using 95% confidence intervals. The SAP will 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.

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 in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4186 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 10100 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 291822 0
University
Name [1] 291822 0
University of Western Sydney
Address [1] 291822 0
University of Western Sydney
School of Medicine
Campbelltown Campus Building 30
Narellan Road, Campbelltown
NSW 2560
Country [1] 291822 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
University of Western Sydney
School of Medicine
Campbelltown Campus Building 30
Narellan Road, Campbelltown
NSW 2560
Country
Australia
Secondary sponsor category [1] 290485 0
Hospital
Name [1] 290485 0
Campbelltown Hospital
Address [1] 290485 0
Therry Road
Campbelltown NSW 2560
Country [1] 290485 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293340 0
South West Sydney LHD
Ethics committee address [1] 293340 0
Liverpool Hospital Eastern Campus
Corner of Lachlan and Hart Streets
Liverpool NSW 2170
Ethics committee country [1] 293340 0
Australia
Date submitted for ethics approval [1] 293340 0
Approval date [1] 293340 0
09/03/2015
Ethics approval number [1] 293340 0
hrec/15/lpool/14

Summary
Brief summary
There is currently no randomised controlled trial (RCT) evidence that treating gestational diabetes (GDM) prior to 24-28 weeks gestation benefits babies or their mothers, and there is potential for harm through fetal undernutrition, inappropriately medicalising some pregnancies, and increasing overall clinical workload. We are planning an RCT testing whether GDM treatment from <20 weeks gestation (‘booking GDM’) is associated with benefit or harm. This pilot study aims to have midwives and women with GDM risk factors review the study plan and to pilot the study procedures. The pilot is a full RCT of 100 women, 20 of whom are expected to have GDM.
Trial website
Trial related presentations / publications
1. D Simmons, J Nema, L Vizza, A Robertson, R Dahlal, R Rajagopal. Treatment of booking gestational diabetes the TOBOGM pilot randomized controlled trial. Diabetes UK Professional Conference © 2017 Diabetes UK. Diabetic Medicine 34 (Suppl s1), 36-194
2. David Simmons, Jodie Nema, Annette Robertson, Raymond Dalal, Rohit Rajagopa. Treatment of Booking Gestational diabetes Mellitus: The ToBOGM Pilot. ADS & ADEA Annual Scientific Meeting, 2016 Gold Coast.
Public notes

Contacts
Principal investigator
Name 59458 0
Prof David Simmons
Address 59458 0
University of Western Sydney
Campbelltown, New South Wales 2560
Country 59458 0
Australia
Phone 59458 0
+61437961795
Fax 59458 0
Email 59458 0
da.simmons@westernsydney.edu.au
Contact person for public queries
Name 59459 0
Prof David Simmons
Address 59459 0
University of Western Sydney
Campbelltown, New South Wales 2560
Country 59459 0
Australia
Phone 59459 0
+61437961795
Fax 59459 0
Email 59459 0
da.simmons@westernsydney.edu.au
Contact person for scientific queries
Name 59460 0
Prof David Simmons
Address 59460 0
Campbelltown Campus
Locked Bag 1797
NSW 2560
Country 59460 0
Australia
Phone 59460 0
+61437961795
Fax 59460 0
Email 59460 0
da.simmons@westernsydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary