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Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) schedule of enrolment, interventions and data collection

From: Health Pregnancy, Healthy Baby: testing the added benefits of pregnancy ultrasound scan for child development in a randomised control trial

 

Study period

Enrolment

Intervention

Follow-up

Timepoint

< 22 weeks GA

< 25 weeks GA

< 36 weeks GA

6 weeks postnatally

6 months postnatally

Enrolment

 Eligibility screen

X

    

 Informed consent

X

    

 Random allocation

X

    

Interventions

 Early US

 

X

   

 Early US with messages

 

X

   

 Early and late US with messages

 

X

X

  

Assessments: baseline and antenatal

 Socio-demographic questionnaire

X

    

 Fetal growth assessment

 

X

X

  

 Social support

 

X

X

  

 Maternal and paternal antenatal depression and anxiety

 

X

X

  

 Maternal and paternal antenatal attachment

 

X

X

  

 Maternal and paternal antenatal depression

 

X

X

  

 US experiences questionnaire

 

X

X

  

Outcomes: primary and secondary

 Bayley Scales of Infant and Toddler Development, Third Edition

    

X

 Home Screening Questionnaire

    

X

 Mother/father–infant interaction

    

X

 Perinatal and postnatal information

   

X

 

 Infant behaviour (crying, sleeping, etc.)

   

X

 

 Breastfeeding practices questionnaire

   

X

X

 Maternal and paternal postnatal depression and anxiety

   

X

X

 Social support

   

X

X

 Partner involvement

   

X

X

 Infant growth – weight and length

   

X

X

 Immunisation status

   

X

X

 Clinic attendance

   

X

X

  1. GA gestational age, US ultrasound scan