Table 1 SPIRIT table for CRAFT-RCT
| STUDY PERIOD | ||||||
|---|---|---|---|---|---|---|
| Enrolment | Randomisation | Post-allocation | Close-out | |||
| TIMEPOINT | 14–23 + 6 weeks’ gestation |
At study recruitment (14–23 + 6 weeks’ gestation) | Within 7 days of randomisation | Antenatal until delivery | Delivery | 28 days post-delivery or discharge from hospital (whichever sooner) of the last recruited participant and infant |
| ENROLMENT: | ||||||
| Eligibility screen | X | |||||
| Informed consent | X | |||||
| Allocation | X | |||||
| INTERVENTIONS: | ||||||
| Insert cervical cerclage | X | |||||
| Observation | X | |||||
| ASSESSMENTS: | ||||||
| Appropriate care for as per local unit guidelines | X | X | X | X | X | |
| DATA COLLECTION: | ||||||
| Baseline data (current pregnancy, obstetric and medical history | X | X | ||||
| Randomisation | X | |||||
| Pregnancy visit data | X | X | X | |||
| Current pregnancy outcomes | X | |||||
| Data collection complete | X | |||||