Cerclage outcome by the type of suture material (COTS) study : randomised pilot/feasibility study comparing monofilament (intervention) sutures versus multifilament (comparison) for cervical cerclage

• Main Author: Israfil-Bayli, Fidan
• Published: University of Birmingham 2018
• Subjects: 610; RG Gynecology and obstetrics
• Online Access: https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.760440

COTS provided the necessary information for planning a definitive trial investigating the clinical effectiveness of monofilament non-braided suture materials in reducing pregnancy loss rate following cervical cerclage compared to the traditional multifilament braided sutures. COTS study was a stepwise process, which initially involved retrospective data analysis and later was supported by the evidence from national survey and systematic review. Evidence from retrospective analysis and systematic review confirmed that the research question about the suitability of multifilament/braided sutures in cervical cerclage; and that they may be associated with poor obstetric outcome. The Systematic review confirmed that at the time of writing there were no RCTs addressing this issue. Our national survey proved that this scientific question is of significant interest to the Obstetrical community and that the practice with cerclage varies across the country. Based on the findings of COTS trial, funding was sought from the NIHR HTA programme, and we were successful in being awarded £1.2 million (co-applicant) to conduct a multi-centre randomised controlled trial (RCT): The C-STICH trial Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes Trial.