Cervical InsufficiencyCEPEICNCT02405455
Cerclage vs Cervical Pessary in Women With Cervical Incompetence
A study testing Cerclage and Cervical pessary in people with Cervical Insufficiency, run by Maternal-Infantil Vall d´Hebron Hospital at 1 site in Spain.
Trial summary
Cervical insufficiency (CI), responsible for 8% of preterm births (PB), is used to describe painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of otherwise normal pregnancies. Structural weakness of cervical tissue was thought to cause or contribute to these adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Insufficiency
- What is being tested?
- Cerclage and Cervical pessary
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Mar 2021
- 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
- Singleton pregnancy
- Minimum age: 18 years
- Previous PB based on CI (primary intervention, <16 weeks) or in case of previous PB and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, <24 weeks). Women are randomised (1:1) either to cervical cerclage or pessary treatment.
Who cannot join
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- Threatened preterm labour at time of randomization
- Spontaneous rupture of membranes at time of randomization
- Chorioamnionitis at time of randomization
- Active vaginal bleeding
- Placenta previa
Trial locations and contacts
1 site in 1 country.
About this study
Cervical insufficiency (CI), responsible for 8% of preterm births (PB), is used to describe painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of otherwise normal pregnancies. Structural weakness of cervical tissue was thought to cause or contribute to these adverse outcomes. The term has also been applied to women with one or two such losses/births or at risk for second-trimester pregnancy loss/birth. Cervical pessary and cervical cerclage are both considered as preventive treatments in women at risk for PB. This study aims to demonstrate that the cervical pessary could reduce the preterm birth rate before 37 weeks of gestation in women with prior PB due to cervical insufficiency or in women with prior PB and a short cervix in the current pregnancy.
Read the detailed description
Methods/Design: This is an open-label, pilot, multicentre, prospective, randomised controlled trial (RCT). Enrolees are women with singleton pregnancies and previous PB based on CI (primary intervention, <16 weeks) or in case of previous PB and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, <24 weeks). Women are randomised (1:1) either to cervical cerclage or pessary treatment. The primary outcome is the spontaneous preterm birth rate before 34 weeks of gestation. The sample size was calculated, as a pilot study, based on the estimated population that we will be able to recruit during the duration of the trial: 60 women, 30 for each group (cervical cerclage and cervical pessary group) to observe, at least a reduction in the PB rate < 34 weeks from 34% to 27% in the pessary group, as does cerclage.
Discussion: The outcome of this study will show the effectiveness of a cervical cerclage and of a cervical pessary in this group of patients.
- Conditions
- Cervical Insufficiency
- Being tested
- Cerclage, Cervical pessary
- Keywords
- cervical insufficiency, cervical cerclage, cervical pessary
- 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.
CerclageProcedure or surgery
Surgical procedure which consists of a strong suture being inserted into and around the cervix to close it.
Cervical pessaryDevice
The Arabin cervical pessary, which is CE-certified for preventing spontaneous preterm birth (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC). It is a vaginal device which is used to treat pregnant women for preventing spontaneous preterm birth. This device can be easily placed around the uterine cervix without pain.
| Study group | Role | What they receive |
|---|---|---|
| Cerclage | Experimental | Cervical cerclage. Receives: Procedure: Cerclage |
| Cervical pessary | Experimental | Cervical pessary Receives: Device: Cervical pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous delivery before 34 complete weeks
Spontaneous delivery before 34 complete weeks
Measured: Before 34 weeks of gestation
Secondary outcomes (8)
Spontaneous delivery before 28 complete weeks
Spontaneous delivery before 28 complete weeks
Measured: Before 28 weeks of gestation
Spontaneous delivery before 37 complete weeks
Spontaneous delivery before 37 complete weeks
Measured: Before 37 weeks of gestation
Foetal and neonatal death
Foetal and neonatal death
Measured: During pregnancy and during the first 28 days of newborn or NICU stay
Neonatal morbidity
Neonatal morbidity
Measured: 28 days of newborn or during NICU stay
Maternal side effects
Maternal side effects
Measured: During pregnancy
Maternal morbidity
Maternal morbidity
Measured: during pregnancy
Number of participants with chorioamnionitis infection
Number of participants with chorioamnionitis infection
Measured: During pregnancy
Hospitalisation for threatened preterm labour
Hospitalisation for threatened preterm labour
Measured: During pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical InsufficiencyStudies 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
- Model description
- Cervical pessary vs. Cervical cerclage
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
- Investigators
- Maria Goya, PhD, Principal investigator, Hospital Vall d'HebrónAndrea Gascón, MD, Principal investigator, Hospital Vall d'Hebrón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405455
- Sponsor's protocol ID
- CEPEIC
- Acronym
- CEPEIC
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2015
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerclage vs Cervical Pessary in Women With Cervical Incompetence
- ClinicalTrials.gov ID
- NCT02405455
- Acronym / sponsor ID
- CEPEIC / CEPEIC
- Conditions
- Cervical Insufficiency
- Keywords
- cervical insufficiency, cervical cerclage, cervical pessary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maternal-Infantil Vall d´Hebron HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 1 Apr 2015 (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.
Cervical insufficiency (CI), responsible for 8% of preterm births (PB), is used to describe painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of otherwise normal pregnancies. Structural weakness of cervical tissue was thought to cause or contribute to these adverse outcomes. The term has also been applied to women with one or two such losses/births or at risk for second-trimester pregnancy loss/birth. Cervical pessary and cervical cerclage are both considered as preventive treatments in women at risk for PB. This study aims to demonstrate that the cervical pessary could reduce the preterm birth rate before 37 weeks of gestation in women with prior PB due to cervical insufficiency or in women with prior PB and a short cervix in the current pregnancy.
Detailed description
Methods/Design: This is an open-label, pilot, multicentre, prospective, randomised controlled trial (RCT). Enrolees are women with singleton pregnancies and previous PB based on CI (primary intervention, <16 weeks) or in case of previous PB and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, <24 weeks). Women are randomised (1:1) either to cervical cerclage or pessary treatment. The primary outcome is the spontaneous preterm birth rate before 34 weeks of gestation. The sample size was calculated, as a pilot study, based on the estimated population that we will be able to recruit during the duration of the trial: 60 women, 30 for each group (cervical cerclage and cervical pessary group) to observe, at least a reduction in the PB rate < 34 weeks from 34% to 27% in the pessary group, as does cerclage.
Discussion: The outcome of this study will show the effectiveness of a cervical cerclage and of a cervical pessary in this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cervical pessary vs. Cervical cerclage
| Arm | Type | Receives |
|---|---|---|
| Cerclage | Experimental | Procedure: CerclageCervical cerclage. |
| Cervical pessary | Experimental | Device: Cervical pessaryCervical pessary |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Minimum age: 18 years
- Previous PB based on CI (primary intervention, <16 weeks) or in case of previous PB and a short cervical length in current pregnancy ≤ 25 mm (secondary intervention, <24 weeks). Women are randomised (1:1) either to cervical cerclage or pessary treatment.
Key exclusion criteria (6 listed)
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- Threatened preterm labour at time of randomization
- Spontaneous rupture of membranes at time of randomization
- Chorioamnionitis at time of randomization
- Active vaginal bleeding
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 |
|---|---|---|
| CerclageSurgical procedure which consists of a strong suture being inserted into and around the cervix to close it. | Procedure or surgery | Cerclage |
| Cervical pessaryThe Arabin cervical pessary, which is CE-certified for preventing spontaneous preterm birth (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC). It is a vaginal device which is used to treat pregnant women for preventing spontaneous preterm birth. This device can be easily placed around the uterine cervix without pain. | Device | Cervical pessary |
Primary outcome
Spontaneous delivery before 34 complete weeks
Time frame: Before 34 weeks of gestation
Spontaneous delivery before 34 complete weeks
8 secondary outcomes
Spontaneous delivery before 28 complete weeks
Time frame: Before 28 weeks of gestation
Spontaneous delivery before 37 complete weeks
Time frame: Before 37 weeks of gestation
Foetal and neonatal death
Time frame: During pregnancy and during the first 28 days of newborn or NICU stay
Neonatal morbidity
Time frame: 28 days of newborn or during NICU stay
Maternal side effects
Time frame: During pregnancy
Maternal morbidity
Time frame: during pregnancy
Number of participants with chorioamnionitis infection
Time frame: During pregnancy
Hospitalisation for threatened preterm labour
Time frame: During pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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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.
Maria Goya, PhD principal investigator
Hospital Vall d'Hebrón
Andrea Gascón, MD principal investigator
Hospital Vall d'Hebrón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerclage and Cervical pessary in people with Cervical Insufficiency, run by Maternal-Infantil Vall d´Hebron Hospital at 1 site in Spain.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spontaneous delivery before 34 complete weeks (time frame: Before 34 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2021.