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 |