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