Skip to main content

Table 2 Schedule of study-related assessments/procedures

From: The PLANES study: a protocol for a randomised controlled feasibility study of the placental growth factor (PlGF) blood test-informed care versus standard care alone for women with a small for gestational age fetus at or after 32 + 0 weeks’ gestation

Procedure

aScreening

aBaseline

Study visit 1

Study visit 2

Study visit 3

Delivery

Postnatal

End of study

Global outcomes

 Review of medical history

X

       

 Review of medication

X

       

 Maternal assessment

Blood pressure

X

 

X

X

X

   

Pulse

X

 

X

X

X

   

Urine dip

X

 

X

X

X

   

 Fetal assessment

Ultrasound (growth, liquor, and UA Doppler)

X

       

cCTG

X

       

 Eligibility assessment

X

       

 Informed consent

 

X

      

 Randomisation

 

X

      

 Blood sample collection

 

X

X

X

X

   

 Qualitative: women/partner

 

X

     

X

 Qualitative: clinician

       

X

 Health economic: EQ-5D-5 L

 

X

   

X

  

 Health economic: CEQ

     

X

  

 Delivery outcomes

     

X

  

 Maternal postnatal outcomes

      

X

 

 Neonatal postnatal outcomes

      

X

 

 End of study outcomes

       

X

bConcealed—standard care pathway

 Adverse event reporting

       

X

 Collection of standard care outcomes

       

X

cRevealed—normal group pathway

 Maternal assessment

BP

  

X

X

X

X

X

 

Pulse

  

X

X

X

X

X

 

Urine dip

  

X

X

X

   

 Fetal assessment

Ultrasound (growth, liquor, and UA Doppler)

  

X

X

X

   

cCTG

  

X

X

X

   

 Adverse event reporting

  

X

X

X

X

X

X

 Blood sample collection

  

X

X

X

   

dRevealed—abnormal group pathway

Maternal assessment

BP

  

X

X

X

X

X

 

Pulse

  

X

X

X

X

X

 

Urine dip

  

X

X

X

   

Fetal assessment

Ultrasound (growth, liquor and UA Doppler)

  

X

X

X

   

cCTG

  

X

X

X

   

MCA and DV Doppler

  

X

X

X

   

Adverse event reporting

  

X

X

X

X

X

X

  1. aFor some participants, the decision to take part in the study may be within 24 h; in such circumstances, baseline assessments/procedures will take place at randomisation
  2. bParticipants to be managed as per local standard practise
  3. cStudy visits to take place every 2 weeks up to delivery or 40 + 0 wGA
  4. dStudy visits to take place every 72 h up to delivery from 36 + 0 wGA