{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T23:37:03Z","timestamp":1772840223119,"version":"3.50.1"},"reference-count":4,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,9,28]],"date-time":"2021-09-28T00:00:00Z","timestamp":1632787200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,9,28]],"date-time":"2021-09-28T00:00:00Z","timestamp":1632787200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","award":["13\/04\/107"],"award-info":[{"award-number":["13\/04\/107"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2021,12]]},"abstract":"Abstract<\/jats:title>\n Background<\/jats:title>\n Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical\/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior.<\/jats:p>\n <\/jats:sec>\n Methods<\/jats:title>\n A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (\u2264 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (\u2264 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials.<\/jats:p>\n <\/jats:sec>\n Discussion<\/jats:title>\n Optimising established interventions to prevent preterm birth is important in reducing perinatal mortality rates.<\/jats:p>\n <\/jats:sec>\n Trial registration<\/jats:title>\n ISRCTN 15373349<\/jats:ext-link>. Registered before recruitment on 03 December 2014 prior to first recruit.<\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s13063-021-05629-3","type":"journal-article","created":{"date-parts":[[2021,9,28]],"date-time":"2021-09-28T12:03:36Z","timestamp":1632830616000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["C-STICH: Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes\u2014a multicentre randomised controlled trial"],"prefix":"10.1186","volume":"22","author":[{"given":"Fidan","family":"Israfil-Bayli","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9817-4313","authenticated-orcid":false,"given":"Victoria Hodgetts","family":"Morton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine A.","family":"Hewitt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew K.","family":"Ewer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jim","family":"Gray","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Norman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christoph","family":"Lees","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nigel A. B.","family":"Simpson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Shennan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Konstantinos","family":"Tryposkiadis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Max","family":"Hughes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Daniels","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Brocklehurst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katie","family":"Morris","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lee","family":"Middleton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philip","family":"Toozs-Hobson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,9,28]]},"reference":[{"issue":"6198","key":"5629_CR1","doi-asserted-by":"publisher","first-page":"760","DOI":"10.1126\/science.1251816","volume":"345","author":"R Romero","year":"2014","unstructured":"Romero R, Dey SK, Fisher SJ. Preterm labor: one syndrome, many causes. Science. 2014;345(6198):760\u20135. https:\/\/doi.org\/10.1126\/science.1251816.","journal-title":"Science."},{"issue":"15","key":"5629_CR2","doi-asserted-by":"publisher","first-page":"1584","DOI":"10.3109\/14767058.2013.870551","volume":"27","author":"F Israfil-Bayli","year":"2014","unstructured":"Israfil-Bayli F, Toozs-Hobson P, Lees C, Slack M, Daniels J, Vince A, et al. Cervical cerclage and type of suture material: a survey of UK consultants\u2019 practice. J Matern Fetal Neonatal Med. 2014;27(15):1584\u20138. https:\/\/doi.org\/10.3109\/14767058.2013.870551.","journal-title":"J Matern Fetal Neonatal Med."},{"issue":"350","key":"5629_CR3","doi-asserted-by":"publisher","first-page":"350ra102","DOI":"10.1126\/scitranslmed.aag1026","volume":"8","author":"LM Kindinger","year":"2016","unstructured":"Kindinger LM, MacIntyre DA, Lee YS, Marchesi JR, Smith A, McDonald JA, et al. Relationship between vaginal microbial dysbiosis, inflammation, and pregnancy outcomes in cervical cerclage. Sci Transl Med. 2016;8(350):350ra102.","journal-title":"Sci Transl Med"},{"key":"5629_CR4","doi-asserted-by":"publisher","unstructured":"Van \u2018t Hooft J, Duffy JM, Daly M, Williamson PR, Meher S, Thom E, et al. A core outcome set for evaluation of interventions to prevent preterm birth. Obstet Gynecol. 2016;127(1):49-58, DOI: https:\/\/doi.org\/10.1097\/AOG.0000000000001195.","DOI":"10.1097\/AOG.0000000000001195"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05629-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05629-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05629-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,9,28]],"date-time":"2021-09-28T12:08:23Z","timestamp":1632830903000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05629-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,28]]},"references-count":4,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["5629"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05629-3","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9,28]]},"assertion":[{"value":"13 November 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 September 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 September 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The Trial has a favourable ethical opinion from Cambridgeshire and Hertfordshire Multi-centre Research Ethics Committee (REC) reference number 14\/EE\/1293. All participants in the trial have provided written informed consent. The consent form used with the project is included for reference (appendix 1)","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"No applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"PTH has received sponsorship or consultancy fees from Ethicon and Boston Scientific both who have manufactured and distributed polypropylene tape products related to Gynaecological surgery.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"664"}}