CEPEIC: Cerclage vs Cervical Pessary in Women With Cervical Incompetence
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cerclage Cervical cerclage. |
Procedure: Cerclage
Surgical procedure which consists of a strong suture being inserted into and around the cervix to close it.
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| Experimental: Cervical pessary Cervical pessary |
Device: Cervical pessary
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.
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Outcome Measures
Primary Outcome Measures
- Spontaneous delivery before 34 complete weeks [Before 34 weeks of gestation]
Spontaneous delivery before 34 complete weeks
Secondary Outcome Measures
- Spontaneous delivery before 28 complete weeks [Before 28 weeks of gestation]
Spontaneous delivery before 28 complete weeks
- Spontaneous delivery before 37 complete weeks [Before 37 weeks of gestation]
Spontaneous delivery before 37 complete weeks
- Foetal and neonatal death [During pregnancy and during the first 28 days of newborn or NICU stay]
Foetal and neonatal death
- Neonatal morbidity [28 days of newborn or during NICU stay]
Neonatal morbidity
- Maternal side effects [During pregnancy]
Maternal side effects
- Maternal morbidity [during pregnancy]
Maternal morbidity
- Number of participants with chorioamnionitis infection [During pregnancy]
Number of participants with chorioamnionitis infection
- Hospitalisation for threatened preterm labour [During pregnancy]
Hospitalisation for threatened preterm labour
Eligibility Criteria
Criteria
Inclusion Criteria:
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Singleton pregnancy
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Minimum age: 18 years
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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.
Exclusion Criteria:
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Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
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Threatened preterm labour at time of randomization
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Spontaneous rupture of membranes at time of randomization
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Chorioamnionitis at time of randomization
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Active vaginal bleeding
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Placenta previa
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Vall d'Hebron | Barcelona | Spain | 08035 |
Sponsors and Collaborators
- Maternal-Infantil Vall d´Hebron Hospital
Investigators
- Principal Investigator: Maria Goya, PhD, Hospital Vall d'Hebrón
- Principal Investigator: Andrea Gascón, MD, Hospital Vall d'Hebrón
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CEPEIC