Table 2.
Compliance with allocated trial intervention
| Control (n = 107) | Intervention (n = 109) | ||
|---|---|---|---|
| Trial blood sample taken | 107 (100%) | 109 (100%) | |
| Blood sample analysed at site | |||
| Yes | 0 (–) | 109 (100%) | |
| No | 107 (100%) | 0 (–) | |
| sFlt-1/PlGF ratio obtained by site and revealed to participant | – | 109 (100%) | |
| Test result (sFlt-1/PlGF ratio) | – | ||
| Mean (SD) | – | 21.1 (23.9) | |
| Median (25th, 75th centile) | – | 14.8 (5.3, 27.8) | |
| Min, max | – | 0.6, 151.1 | |
| Expedited delivery offered | sFlt-1/PlGF ratio < 38 (n = 93) | sFlt-1/PlGF ratio ≥ 38 (n = 16) | |
| Yes | 9 (8%) | 81 (9%) | 15 (94%) |
| No | 98 (92%) | 85 (91%) | 12 (6%) |
| Expedited delivery accepted | |||
| Yes | 9 (100%) | 8 (100%) | 12 (80%) |
| No | 0 (–) | 0 (–) | 33 (20%) |
All data are N (%) unless indicated
1Reasons for offering expedited delivery in the intervention arm with sFlt-1/PlGF ratio < 38 include the following: participant wanted induction of labour even though not indicated (n = 2), clinician decision to deliver baby (n = 5) and participant offered induction for recurrent RFM (n = 1)
2Reasons for not offering expedited delivery in the intervention arm with sFlt-1/PlGF ≥ 38 include the following: clinician decision to continue pregnancy (n = 1)
3Reasons for not accepting expedited delivery in the intervention arm with sFlt-1/PlGF ≥ 38 include the following: would like delivery on midwife-led unit, feels well and baby at the time was moving well (n = 1); discussed results with husband and decided not to accept expedited delivery (n = 1); induction date booked in 1 weeks’ time, would like to stay with that plan (n = 1)