Uterine Cervical IncompetenceNCT01737788
Cervical Occlusion for the Prevention of Preterm Birth
A study testing Cervical occlusion in people with Uterine Cervical Incompetence, run by Niels Jørgen Secher at 23 sites in 9 countries.
Trial summary
The aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Incompetence
- What is being tested?
- Cervical occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 23 sitesin 9 countries
- Study dates
- Aug 2006to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Demonstrated cervical infection.
- Obstetrical complications in the current pregnancy.
- Multiple pregnancies.
- History of a significant abruptio placenta in a previous pregnancy.
Trial locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
Denmark14 sites
Study site
Aalborg, Jutland
Study site
Aarhus, Jutland
Study site
Copenhagen, Region Sjælland
Study site
Gentofte, Copenhagen, Region Sjælland
Study site
Glostrup, Copenhagen, Region Sjælland
Study site
Herlev, Copenhagen, Region Sjælland
Study site
Hillerød, Region Sjælland
Study site
Holbæk, Region Sjælland
Study site
Horsens, Jutland
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
Hvidovre, Region Sjælland
Study site
Kolding, Jutland
Study site
Odense, Funen
Study site
Roskilde, Region Sjælland
Study site
Viborg, Jutland
United Kingdom2 sites
Study site
Liverpool, Lancashire
Study site
London, London
About this study
Official title: 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.
Read the 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.
- Conditions
- Uterine Cervical Incompetence
- Being tested
- Cervical occlusion
- Keywords
- Cervical cerclage, Uterine Cervical Incompetence
- Medical subject headings
- Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical occlusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Trial | Experimental | Therapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (<25mm) Receives: Procedure: Cervical occlusion |
| Prophylactic Trial | Experimental | Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency Receives: Procedure: Cervical occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Take-home baby rate
Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.
Measured: 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
Evaluated as a continuous variable and as a dichotomous variable (<34+0 weeks gestation)
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startAug 2006
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Due to slow recruitment and an interim analysis showing no benefit of occlusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical IncompetenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niels Jørgen Secher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Niels Jørgen Secher, Hvidovre University Hospital
- Investigators
- Niels J Secher, Professor, Principal investigator, Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737788
- Sponsor's protocol ID
- CervOcc-001
- Status last verified
- Nov 2012
- First submitted
- 24 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23331924
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Cervical Cerclage With and Without Occlusion for the Prevention of Preterm Birth in Women Suspected for Cervical Insufficiency
- ClinicalTrials.gov ID
- NCT01737788
- Acronym / sponsor ID
- CervOcc-001
- Conditions
- Uterine Cervical Incompetence
- Keywords
- Cervical cerclage, Uterine Cervical Incompetence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow recruitment and an interim analysis showing no benefit of occlusion.
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Niels Jørgen SecherUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Trial | Experimental | Procedure: Cervical occlusionTherapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (<25mm) |
| Prophylactic Trial | Experimental | Procedure: Cervical occlusionProphylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- Demonstrated cervical infection.
- Obstetrical complications in the current pregnancy.
- Multiple pregnancies.
- History of a significant abruptio placenta in a previous pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical occlusionWomen 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. | Procedure or surgery | Prophylactic Trial, Therapeutic Trial |
Primary outcome
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.
Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.
1 secondary outcome
Gestational age at birth
Time frame: At birth
Results and safety
The study was stopped early (reason given: Due to slow recruitment and an interim analysis showing no benefit of occlusion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
- Derived from this study: PubMed 23331924Brix 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels J Secher, Professor principal investigator
Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical occlusion in people with Uterine Cervical Incompetence, run by Niels Jørgen Secher at 23 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Denmark, United Kingdom, Australia, India, Saudi Arabia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to slow recruitment and an interim analysis showing no benefit of occlusion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.