Statement in response to research article published in Science Translational Medicine

In response to the research article published in Science Translational Medicine on the 3rd August 2016, ‘Relationship between vaginal microbial dysbiosis, inflammation, and pregnancy outcomes in cervical cerclage by Kindinger et al’ and the media response in the Daily Mail and the Daily Telegraph printed on 04/08/2016.

We would like to highlight that research is currently being conducted by the University of Birmingham and Birmingham Women’s NHS Foundation Trust which is designed to fully answer the question of which suture thread to use when performing a cervical cerclage.

C-STICH is an important clinical trial for women who are offered a cervical stitch to help prevent miscarriage or preterm birth. Participants are randomly divided into two groups, to either a thinner single stranded thread or the thicker woven thread. The researchers will collect detailed anonymised data to fully evaluate any differences in outcomes for mothers and babies. The study is currently recruiting participants from over 40 hospitals within the United Kingdom and aims to collect data from 900 women.

This study is large enough to evaluate any differences in all pregnancy outcomes for mothers and babies, including miscarriage, preterm birth, infection and complications that may occur during the procedure, the pregnancy, or upon removing the thread.  It is the prospective and randomised design study needed to provide the definitive answer to the question of which suture thread is superior to use in a cervical cerclage.

Professor Bennett, the lead author on the study published last week, highlights the need for continuing support of a randomised clinical trial such as C-STICH:

"Our current study suggests the thick multifilament thread is associated with increased risk of complications. Even after factoring in the age and overall health of the patient, this effect still existed. However, there are other factors that may influence the risks, such as surgical technique. Only by performing a large randomised clinical trial can we confirm whether the thicker thread itself is triggering complications, to ensure this procedure is as safe and effective as possible for the mother and baby."

C-STICH is an extremely important research trial for the prevention of miscarriage and preterm birth within the United Kingdom and internationally. Finding the best method will prevent miscarriage and premature birth for thousands of women each year. We would therefore encourage all doctors and women to take part in C-STICH. Several of the authors of the above paper are collaborating in the C-STICH trial, including Mr Philip Toozs-Hobson, who reiterates “we welcome this study which adds an important part of the jigsaw, C-STICH will allow us to answer this important question robustly and scientifically, ensuring that pregnant women and babies receive the best possible treatment to prevent miscarriage and preterm birth. Changes in practice without robust evidence can be dangerous and lead to delays in establishing the true answer”.

C-STICH is funded by the National Institute for Health Research's Health Technology Assessment Programme1,2.

For further information, visit the trial webpages, or contact the trial team at cstich@trials.bham.ac.uk.

This statement has been issued on behalf of the C-STICH trial management group and the Chief Investigator Mr Philip Toozs-Hobson.

Notes to editors 

1. The National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme funds research about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS. It is the largest NIHR programme and publishes the results of its research in the Health Technology Assessment journal, with over 700 issues published to date. The journal’s 2014 Impact Factor (5.027) ranked it two out of 85 publications in the Health Care Sciences and Services category. All issues are available for download, free of charge, from the website. The HTA Programme is funded by the NIHR, with contributions from the CSO in Scotland, NISCHR in Wales, and the HSC R&D Division, Public Health Agency in Northern Ireland. www.nets.nihr.ac.uk/programmes/hta

2. The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).

This article presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.