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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
History of Changes
  Purpose

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


Condition Intervention
Uterine Cervical Incompetence
 Procedure: Cervical occlusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Trial of Cervical Cerclage With and Without Occlusion for the Prevention of Preterm Birth in Women Suspected for Cervical Insufficiency

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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 ]

Enrollment: 309
Study Start Date: August 2006
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737788

Locations
Australia, South Australia
Adelaide, South Australia, Australia
Denmark
Odense, Funen, Denmark
Aalborg, Jutland, Denmark
Aarhus, Jutland, Denmark
Horsens, Jutland, Denmark
Kolding, Jutland, Denmark
Viborg, Jutland, Denmark
Copenhagen, Zealand, Denmark
Gentofte, Copenhagen, Zealand, Denmark
Glostrup, Copenhagen, Zealand, Denmark
Herlev, Copenhagen, Zealand, Denmark
Hillerød, Zealand, Denmark
Holbæk, Zealand, Denmark
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
Hvidovre, Zealand, Denmark
Roskilde, Zealand, Denmark
India
New Delhi, India
Saudi Arabia
Makkah, Makkah Province, Saudi Arabia
South Africa
Pretoria, Gauteng, South Africa
Spain
Barcelona, Catalonia, Spain
Sweden
Malmö, Scania, Sweden
Switzerland
Basel, Basel-Stadt, Switzerland
United Kingdom
Liverpool, Lancashire, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Niels Jørgen Secher
Investigators
Principal Investigator: Niels J Secher, Professor Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Niels Jørgen Secher, Professor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01737788     History of Changes
Other Study ID Numbers: CervOcc-001
Study First Received: November 24, 2012
Last Updated: November 29, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Hvidovre University Hospital:
Cervical cerclage
Uterine Cervical Incompetence

Additional relevant MeSH terms:
Uterine Cervical Incompetence
Premature Birth
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
 Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications

ClinicalTrials.gov processed this record on May 19, 2013