Cerclage Suture Type for an Insufficient Cervix and its effect on Health (C-STICH)
THE MAIN TRIAL FEATURES:
- A multi-centre randomised controlled trial covering obstetrics and gynaecology centres nationwide.
- Funded by the National Institute for Health Research Health Technology Assessment Programme (NIHR HTA).
- Chief Investigator for C-Stich is Mr Philip Toozs-Hobson.
- Birmingham Clinical Trials Unit (University of Birmingham) is the CTU from which C-Stich is coordinated, with Birmingham Women's & Children's NHS FT acting as Sponsor.
- The target recruitment is 2050 patients by 30th June 2020.
- Participating women will be randomly allocated to either a monofilament or braided suture.
- The primary objective is to examine the effect of using a monofilament suture material compared with a braided suture material on pregnancy loss rate (defined as miscarriage, stillbirth, neonatal death in the first week of life) and neonatal mortality up to 7 days post-delivery in women presenting with an insufficient cervix and treated with cervical cerclage.
For the Trial Schema click here