Cervical Occlusion for the Prevention of Preterm Birth

November 29, 2012 updated by: Niels Jørgen Secher

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

309

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
  • Denmark
    • Funen
      • Odense, Funen, Denmark
    • Jutland
      • Aalborg, Jutland, Denmark
      • Aarhus, Jutland, Denmark
      • Horsens, Jutland, Denmark
      • Kolding, Jutland, Denmark
      • Viborg, Jutland, Denmark
    • Zealand
      • Copenhagen, Zealand, Denmark
      • Gentofte, Copenhagen, Zealand, Denmark
      • Glostrup, Copenhagen, Zealand, Denmark
      • Herlev, Copenhagen, Zealand, Denmark
      • Hillerød, Zealand, Denmark
      • Holbæk, Zealand, Denmark
      • Hvidovre, Zealand, Denmark
        • Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
      • Roskilde, Zealand, Denmark
  • India
      • New Delhi, India
  • Saudi Arabia
    • Makkah Province
      • Makkah, Makkah Province, Saudi Arabia
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa
  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain
  • Sweden
    • Scania
      • Malmö, Scania, Sweden
  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland
  • United Kingdom
      • London, United Kingdom
    • Lancashire
      • Liverpool, Lancashire, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The physician in charge considered that a cerclage was indicated.
  • Gestational age between 12 and 27 completed weeks.
  • Previous late mid-trimester miscarriage, or spontaneous preterm labour and delivery before 28 weeks with or without previous cerclages.
  • Previous cerclage because of short cervix.
  • Confirmed gestational age defined as gestational age estimated by ultrasound at less than or equal to 22+0 weeks, and/or certain last menstrual period.
  • Vaginal infection treated before cerclage.
  • Ability to read and understand the relevant national language.
  • Consent obtained in accordance with specifications of the local research ethics committee.
  • 18 years or more of age and legally competent.

Exclusion Criteria:

  • Demonstrated cervical infection.
  • Obstetrical complications in the current pregnancy.
  • Multiple pregnancies.
  • History of a significant abruptio placenta in a previous pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic Trial
Therapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (<25mm)
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.
Experimental: Prophylactic Trial
Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Take-home baby rate
Time Frame: Neonates will be followed for the duration of stay in the neonatal intensive care unit, an expected average of 28 days with a minimum of 0 days up to a maximum of 98 days.
Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.
Neonates will be followed for the duration of stay in the neonatal intensive care unit, an expected average of 28 days with a minimum of 0 days up to a maximum of 98 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational age at birth
Time Frame: At birth
Evaluated as a continuous variable and as a dichotomous variable (<34+0 weeks gestation)
At birth

Other Outcome Measures

Outcome Measure
Time Frame
Days of admission to the neonatal intensive care unit
Time Frame: Neonates will be followed for the duration of stay in the neonatal intensive care unit, an expected average of 28 days with a minimum of 0 days up to a maximum of 98 days.
Neonates will be followed for the duration of stay in the neonatal intensive care unit, an expected average of 28 days with a minimum of 0 days up to a maximum of 98 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niels Jørgen Secher

Investigators

  • Principal Investigator: Niels J Secher, Professor, Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 24, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 29, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CervOcc-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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