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Table 1 Schedule of enrolment, interventions and assessments

From: Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial

   Study period
    Post-allocation Close-out
  Enrolment Allocation Time periods after injection 1–14 days post birth From perinatal database
TIMEPOINT** 30 min 60 min 90 min
ENROLMENT:
Eligibility screening X X      
Signed consent form X       
Randomisation   X      
INTERVENTIONS:
Sterile water injection   X      
Normal Saline placebo injection   X      
Vapocoolant spray   X      
ASSESSMENTS:
Cervical dilation   X      
VAS of labour pain prior to injections   X      
VAS of injection pain   X      
VAS of labour pain post injection    X X X   
At least 30% reduction in VAS of pain    X     
At least 50% reduction in VAS of pain    X     
Pharmacological analgesia use   X      X
Non-pharmacological analgesia use   X      X
Duration of labour        X
Augmentation of labour        X
Mode of birth        X
Estimated blood loss at birth        X
Apgar scores        X
Type of neonatal resuscitation        X
Admission to nursery        X
Duration of hospital stay        X
Breastfeeding at discharge        X
Postnatal survey       X  
Economic analysis        X