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Table 1 SPIRIT table for CRAFT-RCT

From: CRAFT (Cerclage after full dilatation caesarean section): protocol of a mixed methods study investigating the role of previous in-labour caesarean section in preterm birth risk

  STUDY PERIOD
Enrolment Randomisation Post-allocation    Close-out
TIMEPOINT 14–23 + 6 weeks’ gestation At study recruitment
(14–23 + 6 weeks’ gestation)
Within 7 days of randomisation Antenatal until delivery Delivery 28 days post-delivery or discharge from hospital (whichever sooner) of the last recruited participant and infant
ENROLMENT:
Eligibility screen X      
Informed consent X      
Allocation   X     
INTERVENTIONS:
Insert cervical cerclage    X    
Observation    X    
ASSESSMENTS:
Appropriate care for as per local unit guidelines X X X X X  
DATA COLLECTION:
Baseline data (current pregnancy, obstetric and medical history X     X  
Randomisation   X     
Pregnancy visit data   X X X   
Current pregnancy outcomes      X  
Data collection complete       X