Objectives:
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To determine if an emergency cervical cerclage (ECC) reduces pregnancy loss (miscarriage, termination of pregnancy, stillbirth or neonatal death within 7 days of delivery) in women who present with cervical dilatation sufficient to allow exposure of the unruptured, fetal membranes at or below the level of the external os between 16+0 and 27+6 weeks.
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To follow up all surviving babies to 2 years of age to determine general health and medium term neurodevelopmental outcomes.
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To determine the complication rates at ECC:
- Including the number of women who suffer iatrogenic rupture of membranes during the procedure.
- The rate of insertion failure in women allocated to have an ECC inserted.
- To explore predictors of successful ECC placement such as magnitude of dilatation.
Trial Design:
A randomised controlled, multicentre trial (RCT) with an internal pilot, a nested qualitative process evaluation and cost-effectiveness analysis. Following the internal pilot and nested qualitative evaluation a prospective observational cohort study was developed to run alongside the RCT.
Participant Population and Sample Size for RCT:
Pregnant women presenting at 16+0 ‑ 27+6 weeks, with premature cervical dilatation and exposed, unruptured fetal membranes will be invited to take part in a RCT of ECC vs no cervical cerclage.
- Setting: Maternity units within the UK.
- Sample size: up to 260 women.
Observational Cohort
Consented observational cohort added following pilot review. This will supplement effectiveness evaluation. The inclusion and exclusion criteria for the cohort remains the same as the RCT. All outcome measures collected in the RCT will be collected in the observational cohort including the two year outcomes.