Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial
BACKGROUND: Cervical incompetence is one of the causes of preterm birth and mid-trimester pregnancy loss. Cervical cerclage is a surgical procedure to treat cervical incompetence. Cervical cerclage reduces the incidence of preterm birth in women at risk of recurrent preterm birth, without a statisti...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221668/ https://www.ncbi.nlm.nih.gov/pubmed/25348257 http://dx.doi.org/10.1186/1745-6215-15-415 |
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author | Israfil-Bayli, Fidan Toozs-Hobson, Philip Lees, Christoph Slack, Mark Ismail, Khaled |
author_facet | Israfil-Bayli, Fidan Toozs-Hobson, Philip Lees, Christoph Slack, Mark Ismail, Khaled |
author_sort | Israfil-Bayli, Fidan |
collection | PubMed |
description | BACKGROUND: Cervical incompetence is one of the causes of preterm birth and mid-trimester pregnancy loss. Cervical cerclage is a surgical procedure to treat cervical incompetence. Cervical cerclage reduces the incidence of preterm birth in women at risk of recurrent preterm birth, without a statistically significant reduction in perinatal mortality or neonatal morbidity. Multifilament/braided sutures such as Mersilene tape have been traditionally used for cervical cerclage. Braided sutures, particularly mesh-like non-absorbable sutures, have been associated with an increased risk of infection and, hence, some obstetricians prefer to use monofilament/non-braided sutures. However, these claims are not substantiated by any scientific or clinical evidence. We propose a pilot/feasibility study which will provide 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. METHODS/DESIGN: Women eligible for elective or ultrasound-indicated cerclage at 12 to 21 + 6 weeks of gestation will be randomised to having the procedure using either a monofilament non-braided suture (Ethilon) or a Multifilament braided suture (Mersilene tape) inserted using a McDonald technique. Consent for participation in the Cerclage outcome by the type of suture (COTS) study will be obtained from each eligible participant. CLINICAL TRIALS REGISTRATION: COTS is registered with the International Standard Research for Clinical Trials (ISRCTN17866773). Registered on 27 March 2013. |
format | Online Article Text |
id | pubmed-4221668 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42216682014-11-07 Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial Israfil-Bayli, Fidan Toozs-Hobson, Philip Lees, Christoph Slack, Mark Ismail, Khaled Trials Study Protocol BACKGROUND: Cervical incompetence is one of the causes of preterm birth and mid-trimester pregnancy loss. Cervical cerclage is a surgical procedure to treat cervical incompetence. Cervical cerclage reduces the incidence of preterm birth in women at risk of recurrent preterm birth, without a statistically significant reduction in perinatal mortality or neonatal morbidity. Multifilament/braided sutures such as Mersilene tape have been traditionally used for cervical cerclage. Braided sutures, particularly mesh-like non-absorbable sutures, have been associated with an increased risk of infection and, hence, some obstetricians prefer to use monofilament/non-braided sutures. However, these claims are not substantiated by any scientific or clinical evidence. We propose a pilot/feasibility study which will provide 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. METHODS/DESIGN: Women eligible for elective or ultrasound-indicated cerclage at 12 to 21 + 6 weeks of gestation will be randomised to having the procedure using either a monofilament non-braided suture (Ethilon) or a Multifilament braided suture (Mersilene tape) inserted using a McDonald technique. Consent for participation in the Cerclage outcome by the type of suture (COTS) study will be obtained from each eligible participant. CLINICAL TRIALS REGISTRATION: COTS is registered with the International Standard Research for Clinical Trials (ISRCTN17866773). Registered on 27 March 2013. BioMed Central 2014-10-27 /pmc/articles/PMC4221668/ /pubmed/25348257 http://dx.doi.org/10.1186/1745-6215-15-415 Text en © Israfil-Bayli et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Israfil-Bayli, Fidan Toozs-Hobson, Philip Lees, Christoph Slack, Mark Ismail, Khaled Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial |
title | Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial |
title_full | Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial |
title_fullStr | Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial |
title_full_unstemmed | Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial |
title_short | Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial |
title_sort | cerclage outcome by the type of suture material (cots): study protocol for a pilot and feasibility randomised controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221668/ https://www.ncbi.nlm.nih.gov/pubmed/25348257 http://dx.doi.org/10.1186/1745-6215-15-415 |
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