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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01737788




Registration number
NCT01737788
Ethics application status
Date submitted
24/11/2012
Date registered
30/11/2012
Date last updated
30/11/2012

Titles & IDs
Public title
Cervical Occlusion for the Prevention of Preterm Birth
Scientific title
Randomised Trial of Cervical Cerclage With and Without Occlusion for the Prevention of Preterm Birth in Women Suspected for Cervical Insufficiency
Secondary ID [1] 0 0
CervOcc-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Cervical Incompetence 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Cervical occlusion

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

Experimental: Prophylactic Trial - Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency


Treatment: Surgery: 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.

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Take-home baby rate - Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.
Timepoint [1] 0 0
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 [1] 0 0
Gestational age at birth - Evaluated as a continuous variable and as a dichotomous variable (<34+0 weeks gestation)
Timepoint [1] 0 0
At birth

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Demonstrated cervical infection.

- Obstetrical complications in the current pregnancy.

- Multiple pregnancies.

- History of a significant abruptio placenta in a previous pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Funen
Country [2] 0 0
Denmark
State/province [2] 0 0
Jutland
Country [3] 0 0
Denmark
State/province [3] 0 0
Zealand
Country [4] 0 0
India
State/province [4] 0 0
New Delhi
Country [5] 0 0
Saudi Arabia
State/province [5] 0 0
Makkah Province
Country [6] 0 0
South Africa
State/province [6] 0 0
Gauteng
Country [7] 0 0
Spain
State/province [7] 0 0
Catalonia
Country [8] 0 0
Sweden
State/province [8] 0 0
Scania
Country [9] 0 0
Switzerland
State/province [9] 0 0
Basel-Stadt
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Lancashire
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Niels Jørgen Secher
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01737788
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niels J Secher, Professor
Address 0 0
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01737788