Abstract | 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.
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Authors | Fidan Israfil-Bayli, Philip Toozs-Hobson, Christoph Lees, Mark Slack, Khaled Ismail |
Journal | Trials
(Trials)
Vol. 15
Pg. 415
(Oct 27 2014)
ISSN: 1745-6215 [Electronic] England |
PMID | 25348257
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Nylons
- Polyethylene Terephthalates
- Lavsan
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Topics |
- Abortion, Spontaneous
(prevention & control)
- Adult
- Cerclage, Cervical
(instrumentation, methods)
- Clinical Protocols
- England
- Equipment Design
- Feasibility Studies
- Female
- Gestational Age
- Humans
- Nylons
- Pilot Projects
- Polyethylene Terephthalates
- Pregnancy
- Premature Birth
(prevention & control)
- Research Design
- Suture Techniques
(instrumentation)
- Sutures
- Time Factors
- Treatment Outcome
- Ultrasonography, Prenatal
- Uterine Cervical Incompetence
(diagnostic imaging, surgery)
- Young Adult
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