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Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial.

AbstractBACKGROUND:
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.
AuthorsFidan Israfil-Bayli, Philip Toozs-Hobson, Christoph Lees, Mark Slack, Khaled Ismail
JournalTrials (Trials) Vol. 15 Pg. 415 (Oct 27 2014) ISSN: 1745-6215 [Electronic] England
PMID25348257 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Nylons
  • Polyethylene Terephthalates
  • Lavsan
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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