Extrait

Background and study aims Every year about 3750 women in the UK will have complications where their cervix (the neck of the womb) becomes loose and opens during the early months of pregnancy. This can require a stitch being sewn into the cervix in an attempt to keep it closed. This is often referred to as ‘cervical suture’ or ‘cervical cerclage’. If this procedure is not performed the cervix can open too early and can result in a miscarriage or premature birth. Inserting a stitch into the cervix does not guarantee to keep the cervix closed, but it can sometimes allow the pregnancy to continue for a few more weeks. The stitches used for this procedure are available in different sizes and materials. Some of the stitch threads are made from a single, smooth fibre (e.g. nylon) while others are composed of many fibres which are woven to form a fine braided or net-like structure. A survey of consultants in the UK has shown most use braided threads when they stitch the cervix merely because it is the traditional material used and because it is thought to offer strength and enhanced support to an otherwise loose cervix. However, this survey also revealed that some surgeons thought that bacteria could grow more easily in the spaces of the braided thread than on the surface of the monofilament line. This could increase the risk of infection, which might cause an early labour. It is therefore essential to investigate whether the type of thread used for stitching the cervix increases or decreases the risk of infection. This study will therefore compare outcomes from the use of either smooth or braided stitches during this procedure. Who can participate? Eligible pregnant women can opt to be part of the study if they are due a planned stitch in their cervix between 12 and 22 weeks into their pregnancy. What does the study involve? The best way to compare the two methods of treatment is to undertake a clinical trial where the nature of the stitch used is decided randomly. Participants will be randomly allocated to receive either a monofilament suture or a braided suture to place a cervical cerclage. Apart from the type of thread used, participants will receive identical medical treatment to those not taking part in the study. Information will be collected concerning the risk of losing a baby during pregnancy or within a week of birth, the number of weeks the pregnancy lasted prior to birth, whether the baby was admitted to a Neonatal Unit, the length of stay in the unit and any sign of vaginal or womb infection. What are the possible benefits and risks of participating? As any participant has been advised that they will need a cervical stitch they will not gain any additional benefit by taking part in the study. Similarly, there are no additional risks associated with taking part above those associated with the cerclage itself. Seeing what bacteria grow on the vaginal swab and removed stitch will help doctors decide if the woman taking part in the study needs any antibiotics. By taking part participants will help doctors decide which is best type of thread to offer to women requiring a cervical stitch in the future. The results of this study can potentially save the lives of more than 300 babies a year in the UK alone who would otherwise be at risk of severe prematurity or miscarriage. Where is the study run from? Birmingham Women's Hospital NHS Foundation Trust, Queen Elizabeth Hospital, Edinburgh Royal Infirmary, King's College Hospital, Leeds General Infirmary, Royal Victoria Infirmary, University College Hospital, St. Mary's Hospital, Barts and The London Hospital, University College London Hospital, St. Thomas' Hospital, Hammersmith / Queen Charlotte's Hospital, Chelsea and Westminster Hospital (UK). When is the study starting and how long is it expected to run for? March 2015 to March 2018. Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK). Who is the main contact? 1. Ms Joy Rahman (public) [email protected] 2. Professor Khalid Ismail (scientific) [email protected]

Critère d'inclusion

• Insufficient cervix

Liens

• ictrp
• isrctn