NCT01737788

Cervical Occlusion for the Prevention of Preterm Birth

Randomised Trial of Cervical Cerclage With and Without Occlusion for the Prevention of Preterm Birth in Women Suspected for Cervical Insufficiency

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Niels Jørgen Secher · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages.

Detailed description

Cervical weakness and ascending infection have long been considered important causes of preterm birth. Cervical occlusion could theoretically be used for the treatment of cervical weakness and to protect the cervix against infection. A cervical cerclage could be placed to increase the cervical resistance, and occlusion of the external os could be performed to retain the cervical mucus plug thereby preventing infection. The aim of this multicentre, stratified, randomised controlled trial was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with prophylactic and therapeutic cervical cerclages.

Conditions

• Uterine Cervical Incompetence

Interventions

Type	Name	Description
PROCEDURE	Cervical occlusion	Women were randomized to receive cervical occlusion or no cervical occlusion in addition to a cervical cerclage (McDonald or Shirodkar cerclage). Cervical occlusion was performed with interrupted or continuous sutures, placed approximately 1 cm deep on each lip, and 0.5 cm apart with a nylon 2-0/3-0 suture.

Timeline

• Start date: 2006-08-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2012-11-30
• Last updated: 2012-11-30

Locations

23 sites across 9 countries: Australia, Denmark, India, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, United Kingdom