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Cervical Occlusion for the Prevention of Preterm Birth

Primary Purpose

Uterine Cervical Incompetence

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cervical occlusion
Sponsored by
Niels Jørgen Secher
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Incompetence focused on measuring Cervical cerclage, Uterine Cervical Incompetence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Therapeutic Trial

Prophylactic Trial

Arm Description

Therapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (<25mm)

Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency

Outcomes

Primary Outcome Measures

Take-home baby rate
Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.

Secondary Outcome Measures

Gestational age at birth
Evaluated as a continuous variable and as a dichotomous variable (<34+0 weeks gestation)

Full Information

First Posted
November 24, 2012
Last Updated
November 29, 2012
Sponsor
Niels Jørgen Secher
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1. Study Identification

Unique Protocol Identification Number
NCT01737788
Brief Title
Cervical Occlusion for the Prevention of Preterm Birth
Official Title
Randomised Trial of Cervical Cerclage With and Without Occlusion for the Prevention of Preterm Birth in Women Suspected for Cervical Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Due to slow recruitment and an interim analysis showing no benefit of occlusion.
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Niels Jørgen Secher

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Incompetence
Keywords
Cervical cerclage, Uterine Cervical Incompetence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Trial
Arm Type
Experimental
Arm Description
Therapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (<25mm)
Arm Title
Prophylactic Trial
Arm Type
Experimental
Arm Description
Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency
Intervention Type
Procedure
Intervention Name(s)
Cervical occlusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Take-home baby rate
Description
Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.
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.
Secondary Outcome Measure Information:
Title
Gestational age at birth
Description
Evaluated as a continuous variable and as a dichotomous variable (<34+0 weeks gestation)
Time Frame
At birth
Other Pre-specified Outcome Measures:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels J Secher, Professor
Organizational Affiliation
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
City
Adelaide
State/Province
South Australia
Country
Australia
City
Odense
State/Province
Funen
Country
Denmark
City
Aalborg
State/Province
Jutland
Country
Denmark
City
Aarhus
State/Province
Jutland
Country
Denmark
City
Horsens
State/Province
Jutland
Country
Denmark
City
Kolding
State/Province
Jutland
Country
Denmark
City
Viborg
State/Province
Jutland
Country
Denmark
City
Copenhagen
State/Province
Zealand
Country
Denmark
City
Gentofte, Copenhagen
State/Province
Zealand
Country
Denmark
City
Glostrup, Copenhagen
State/Province
Zealand
Country
Denmark
City
Herlev, Copenhagen
State/Province
Zealand
Country
Denmark
City
Hillerød
State/Province
Zealand
Country
Denmark
City
Holbæk
State/Province
Zealand
Country
Denmark
Facility Name
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
City
Hvidovre
State/Province
Zealand
Country
Denmark
City
Roskilde
State/Province
Zealand
Country
Denmark
City
New Delhi
Country
India
City
Makkah
State/Province
Makkah Province
Country
Saudi Arabia
City
Pretoria
State/Province
Gauteng
Country
South Africa
City
Barcelona
State/Province
Catalonia
Country
Spain
City
Malmö
State/Province
Scania
Country
Sweden
City
Basel
State/Province
Basel-Stadt
Country
Switzerland
City
Liverpool
State/Province
Lancashire
Country
United Kingdom
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23331924
Citation
Brix N, Secher NJ, McCormack CD, Helmig RB, Hein M, Weber T, Mittal S, Kurdi W, Palacio M, Henriksen TB; CERVO group. Randomised trial of cervical cerclage, with and without occlusion, for the prevention of preterm birth in women suspected for cervical insufficiency. BJOG. 2013 Apr;120(5):613-20. doi: 10.1111/1471-0528.12119. Epub 2013 Jan 18.
Results Reference
derived

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Cervical Occlusion for the Prevention of Preterm Birth

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