None listed
Conditions
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. There is no consensus as to the degree of high blood glucose needed for the diagnosis of GDM or when treatment will be beneficial, due to a lack of high quality evidence. Our randomised trial compares important health outcomes for mothers and babies of treating women with GDM by the current criteria used in New Zealand with newly proposed criteria, that use a lower threshold and will diagnose more women as having GDM. Our results will show which diagnostic criteria is best for the health of mothers and babies, which is more cost-effective, and so provide the necessary information to guide clinical practice and policy in New Zealand, with global relevance.
Interventions
IADPSG Diagnostic Criteria Group classified as normal or GDM based on their 75g OGTT results:
- Normal by IADPSG criteria (fasting plasma glucose <5.1 mmol/L, AND 1 hour <10.0 mmol/L, AND 2 hour <8.5 mmol/L).
- GDM by IADPSG diagnostic criteria (fasting plasma glucose >/=5.1 mmol/L, OR 1 hour >/=10.0mmol/L, OR 2 hour >/=8.5 mmol/L).
The OGTT undertaken at a single occasion only as in routine antenatal care.
Sponsors
University of Auckland, Research Office
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Women with a singleton pregnancy eligible for testing for GDM at 24 to 32 weeks’ gestation, who give written, informed consent.
Exclusion criteria
Women with known diabetes mellitus or previously diagnosed GDM.
Outcome results
None listed