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Cervical Occlusion for the Prevention of Preterm Birth

This study has been terminated.
(Due to slow recruitment and an interim analysis showing no benefit of occlusion.)
Sponsor:
Information provided by (Responsible Party):
Niels Jørgen Secher, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01737788
First received: November 24, 2012
Last updated: November 29, 2012
Last verified: November 2012

November 24, 2012
November 29, 2012
August 2006
August 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.
Same as current
Complete list of historical versions of study NCT01737788 on ClinicalTrials.gov Archive Site
Gestational age at birth [ Time Frame: At birth ] [ Designated as safety issue: No ]
Evaluated as a continuous variable and as a dichotomous variable (<34+0 weeks gestation)
Same as current
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. ] [ Designated as safety issue: No ]
Same as current
 
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Uterine Cervical Incompetence
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: Therapeutic Trial
    Therapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (<25mm)
    Intervention: Procedure: Cervical occlusion
  • Experimental: Prophylactic Trial
    Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency
    Intervention: Procedure: Cervical occlusion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
309
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Denmark,   India,   Saudi Arabia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT01737788
CervOcc-001
Yes
Niels Jørgen Secher, Hvidovre University Hospital
Niels Jørgen Secher
Not Provided
Principal Investigator: Niels J Secher, Professor Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
Hvidovre University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP