Table 1.
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 |