| STUDY PERIOD | |||||
---|---|---|---|---|---|---|
Enrolment | Randomisation | Post-allocation | Â | Â | 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 |