Procedure | Screening & randomisation 14+0-23+6 weeks gestation | Intervention (day 0) 14+0-23+6 weeks gestation | Baseline visit (day) 1–4 weeks after procedure | Follow up visits (if clinically indicated) | Final visit 34+0-38+6 weeks’ gestation | Note review (no visit required) |
---|---|---|---|---|---|---|
Visit window (± days) | −7 to 0 days | Day 0 | 7-28 days | Approximately 2–4 weekly | 3 | Discharge from Hospital or 28 days postnatal |
Informed consent | ✓ | |||||
Medical history and concomitant medications | ✓ | ✓ | Optional | ✓ | ||
Transvaginal ultrasound Scan | ✓ | ✓ | Optional | |||
Biological sample collection | Optional | Optional | Optional | |||
Adverse events (AEs) changes to interventions | ✓ | As needed | ✓ | ✓ | ||
Count of un-used medication | ✓ | |||||
Pessary/Cerclage removal | ✓ |