None listed
Conditions
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).
Interventions
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,
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
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed