Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
309 participants
INTERVENTIONAL
2006-08-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Therapeutic Trial
Therapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (\<25mm)
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.
Prophylactic Trial
Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Obstetrical complications in the current pregnancy.
* Multiple pregnancies.
* History of a significant abruptio placenta in a previous pregnancy.
18 Years
FEMALE
No
Sponsors
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Niels Jørgen Secher
OTHER
Responsible Party
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Niels Jørgen Secher
Professor
Principal Investigators
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Niels J Secher, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
Locations
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Adelaide, South Australia, Australia
Odense, Funen, Denmark
Aalborg, Jutland, Denmark
Aarhus, Jutland, Denmark
Horsens, Jutland, Denmark
Kolding, Jutland, Denmark
Viborg, Jutland, Denmark
Copenhagen, Region Sjælland, Denmark
Gentofte, Copenhagen, Region Sjælland, Denmark
Glostrup, Copenhagen, Region Sjælland, Denmark
Herlev, Copenhagen, Region Sjælland, Denmark
Hillerød, Region Sjælland, Denmark
Holbæk, Region Sjælland, Denmark
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
Hvidovre, Region Sjælland, Denmark
Roskilde, Region Sjælland, Denmark
New Delhi, New Delhi, India
Mecca, Mecca Region, Saudi Arabia
Pretoria, Gauteng, South Africa
Barcelona, Catalonia, Spain
Malmo, Skåne County, Sweden
Basel, Canton of Basel-City, Switzerland
Liverpool, Lancashire, United Kingdom
London, London, United Kingdom
Countries
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References
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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.
Other Identifiers
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CervOcc-001
Identifier Type: -
Identifier Source: org_study_id