Visit number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
---|---|---|---|---|---|---|---|---|---|
Gestation | 10–16 weeks | 10–16 weeks | 12–16 weeks | 18–20 weeks | 28 Weeks | 36 Weeks | Term | Labour/delivery/neonatal | 3 months postnatally |
Screening | Consent | Randomisation | Study visit (could be by telephone) | Study visit | Study visit | Study visit (could be by telephone) | Study visit | Study visit | |
Review inclusion and exclusion criteria | X | ||||||||
Patient information leaflet | X | ||||||||
Consent form | X | ||||||||
Demographics | X | ||||||||
Medical history | X | ||||||||
Height and weight | X | X | |||||||
Maternal anthropometry | X | X | X | ||||||
Bloods for liver function/renal function/full lipid profile/CRP | X | X | |||||||
75 g OGTT (sampling at baseline and 2 hours) | X | X | X | ||||||
Stored sample for inflammatory and metabolic indices | X | X | X | ||||||
Randomisation | X | ||||||||
Study drug dispensed | X | X | |||||||
Unused study drug/packaging returned | X | ||||||||
Review SAEs | X | X | X | X | X | ||||
Complete side effects questionnaire on eCRF | X | X | X | X | X | ||||
Review and record pregnancy complications | X | X | X | X | X | ||||
Saliva samples for cortisol measurements | X | X | X | ||||||
Bodpod measurements | X (OR VISIT 3) | X (OR VISIT 2) | X | X | |||||
Hyperinsulinaemic euglycaemic clamp | X | ||||||||
FMD | X | X | |||||||
MR scan | X | X | |||||||
Labour/delivery information including birth weight, mode of delivery, EBL | X | ||||||||
Cord blood and placenta biopsy | X | ||||||||
Myometrium biopsy (if delivered by CS) | X | ||||||||
Adipose tissue biopsy | X | ||||||||
Baby's weight and anthropometry | X | X | |||||||
Peapod measurements | X | X |
CRP, C reactive protein; CS, caesarean section; EBL, estimated blood loss; eCRF, electronic case report form; FMD, flow mediated dilatation; OGTT, oral glucose tolerance test; SAE, serious adverse event.