Background
Treatment of GDM improves maternal and infant health
So what threshold for diagnosis and then treatment of GDM provides the greatest health benefits without harms?
Systematic review of diagnostic criteria for detection of GDM in women
Aims and objectives of the GEMS Trial
GEMS Trial Hypotheses
Method/Design
Ethics statement
Study design and setting
Trial entry, randomisation and allocation of the study group
Generation of the sequence to which participants will be randomised
Treatment schedules
Data collection and management
Timepoint
| Enrolment | Allocation | Post-allocation | Close-out | ||
---|---|---|---|---|---|---|
Before
34 weeks
|
24 to 34 weeks
|
Antenatal
|
Birth
|
Postnatal
|
Discharge after birth
| |
Enrolment
| ||||||
Eligibility screen
| X | |||||
Informed consent
| X | |||||
Allocation
| X | |||||
Interventions
| ||||||
Lower Criteria Group
| X | X | X | X | X | |
Higher Criteria Group
| X | X | X | X | X | |
Activity/
assessments
| ||||||
Inclusion/
exclusion form
| X | X | ||||
Consent form
| X | |||||
Randomisation
| X | |||||
Standard care for GDM if GDM by criteria allocated
| X | X | X | X | ||
Routine pregnancy care if not GDM by criteria allocated
| X | X | X | X | ||
Pregnancy, birth, and infant forms
| X | |||||
Serious adverse event form
| X | X | X | X | ||
Primary outcome: Large for gestational age
| X | X | ||||
Secondary infant outcomes
| X | X | X | |||
Maternal outcomes
| X | X | X | X |