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Table 1 Schedule of enrolment, intervention, and assessments during the GEMS Trial

From: Lower versus higher diagnostic criteria for the detection of gestational diabetes for reducing maternal and perinatal morbidity: study protocol for the GEMS randomised trial

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