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Cervical Occlusion for the Prevention of Preterm Birth

NCT01737788 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2012-11-30

No results posted yet for this study

Summary

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

Conditions

  • Uterine Cervical Incompetence

Interventions

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.

Sponsors & Collaborators

  • Niels Jørgen Secher

    lead OTHER

Principal Investigators

  • Niels J Secher, Professor · Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Australia
  • Denmark
  • India
  • Saudi Arabia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01737788 on ClinicalTrials.gov