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- Title
Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial.
- Authors
Israfil-Bayli, Fidan; Toozs-Hobson, Philip; Lees, Christoph; Slack, Mark; Ismail, Khaled
- Abstract
<bold>Background: </bold>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. <bold>Methods/design: </bold>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. <bold>Clinical Trials Registration: </bold>COTS is registered with the International Standard Research for Clinical Trials (ISRCTN17866773). Registered on 27 March 2013.
- Publication
Trials, 2014, Vol 15, Issue 1, p415
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/1745-6215-15-415