C-STICH2: emergency cervical cerclage to prevent miscarriage and preterm birth—study protocol for a randomised controlled trial

Abstract Background Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical (ECC) for dilatation with exposed unruptured membranes less common the potential benefits of are certain. A randomised control trial needed accurately assess effectiveness ECC in preventing pregnancy loss compared an expectant approach. Methods C-STICH2 multicentre controlled which women presenting at 16 + 0 27 6 weeks gestation or management. Trial design includes 18 month internal pilot embedded qualitative process evaluation, minimal data set within-trial health economic analysis. Inclusion criteria ≥16 years, singleton pregnancy, external os, 0–27 weeks, informed consent. Exclusion contraindication cerclage, situ previous this pregnancy. Randomisation occurs via online service 1:1 ratio, using minimisation algorithm reduce chance imbalances key prognostic variables (site, dilatation). Primary outcome loss; composite including miscarriage, termination perinatal mortality defined as stillbirth neonatal death first week life. Secondary outcomes include all core PTB. Two-year development will be assessed general Parent Report Children’s Abilities-Revised (PARCA-R) questionnaires. Intended sample size 260 participants (130 each arm) based on 60% rate management arm 40% arm, 90% power alpha 0.05. Analysis by intention-to-treat. Discussion To date there has been one small 23 included twin pregnancies. This along largest observational study ( n = 161) found prolong duration deliveries before 34 gestation. It important generate high quality evidence loss, improve understanding prevalence condition frequency complications associated ECC. An adequately powered RCT provide highest regarding optimum care these their babies. registration ISRCTN Registry ISRCTN12981869 . Registered 13th June 2018.