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 |