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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