Table 3.
Trial schedule—outcomes (pro: patient-reported outcomes)
| Visit 1 Day 0 Randomisation |
Visit 2 Day 7 (±1) |
Visit 3 Day 14 (±1) End of intervention |
Daily online questionnaires | 1 month after delivery | |
| PUQE-24 score | PRO | PRO | PRO | PRO | |
| PUQE well-being score | PRO | PRO | PRO | PRO | |
| Nausea VAS | PRO | PRO | PRO | PRO | |
| Daily vomiting episodes | PRO | PRO | PRO | PRO | |
| Administration of trial medication | PRO | ||||
| Administration of rescue medication | PRO | ||||
| Side effects | Registered by trial personnel | Registered by trial personnel | Registered by trial personnel | PRO | |
| NVPQOL | PRO | PRO | PRO | ||
| HELP-score | PRO | PRO | PRO | ||
| EQ5D-5L | PRO | PRO | PRO | ||
| Modified PSQI | PRO | PRO | PRO | ||
| Patient satisfaction with treatment VAS | PRO | PRO | |||
| Patient consideration of termination of pregnancy | PRO | PRO | PRO | ||
| Request for dosage increase | Registered by trial personnel | ||||
| Request for continued treatment | Registered by trial personnel | ||||
| Days on sick leave | PRO | PRO | |||
| Intravenous fluid therapy | PRO | PRO | |||
| Days of hospitalisation | PRO | PRO | |||
| Weight | Measured by trial personnel | Measured by trial personnel | Measured by trial personnel | ||
| Pregnancy outcome including possible malformation and hospitalisation of the new-born | Collected from medical record | ||||
| Treatment failure | Registered by trial personnel at time of event | ||||
PUQE, Pregnancy Unique Quantification of Emesis; VAS, visual analogue score.