Study Stopped
Due to slow recruitment and an interim analysis showing no benefit of occlusion.
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
1 other identifier
interventional
309
9 countries
23
Brief Summary
The aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2006
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 24, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedNovember 30, 2012
November 1, 2012
5 years
November 24, 2012
November 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Take-home baby rate
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 Outcomes (1)
Gestational age at birth
At birth
Other Outcomes (1)
Days of admission to the neonatal intensive care unit
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.
Study Arms (2)
Therapeutic Trial
EXPERIMENTALTherapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (\<25mm)
Prophylactic Trial
EXPERIMENTALProphylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- years or more of age and legally competent.
You may not qualify if:
- Demonstrated cervical infection.
- Obstetrical complications in the current pregnancy.
- Multiple pregnancies.
- History of a significant abruptio placenta in a previous pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Adelaide, South Australia, Australia
Unknown Facility
Odense, Funen, Denmark
Unknown Facility
Aalborg, Jutland, Denmark
Unknown Facility
Aarhus, Jutland, Denmark
Unknown Facility
Horsens, Jutland, Denmark
Unknown Facility
Kolding, Jutland, Denmark
Unknown Facility
Viborg, Jutland, Denmark
Unknown Facility
Copenhagen, Region Sjælland, Denmark
Unknown Facility
Gentofte, Copenhagen, Region Sjælland, Denmark
Unknown Facility
Glostrup, Copenhagen, Region Sjælland, Denmark
Unknown Facility
Herlev, Copenhagen, Region Sjælland, Denmark
Unknown Facility
Hillerød, Region Sjælland, Denmark
Unknown Facility
Holbæk, Region Sjælland, Denmark
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
Hvidovre, Region Sjælland, Denmark
Unknown Facility
Roskilde, Region Sjælland, Denmark
Unknown Facility
New Delhi, New Delhi, India
Unknown Facility
Mecca, Mecca Region, Saudi Arabia
Unknown Facility
Pretoria, Gauteng, South Africa
Unknown Facility
Barcelona, Catalonia, Spain
Unknown Facility
Malmo, Skåne County, Sweden
Unknown Facility
Basel, Canton of Basel-City, Switzerland
Unknown Facility
Liverpool, Lancashire, United Kingdom
Unknown Facility
London, London, United Kingdom
Related Publications (1)
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.
PMID: 23331924DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niels J Secher, Professor
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 24, 2012
First Posted
November 30, 2012
Study Start
August 1, 2006
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
November 30, 2012
Record last verified: 2012-11