Cerclage vs Cervical Pessary in Women With Cervical Incompetence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cerclage vs Cervical Pessary in Women With Cervical Incompetence

Conditions
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Cervical Insufficiency

Intervention / Treatment
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* Procedure: Cerclage
* Device: Cervical pessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cervical pessary vs. Cervical cerclage
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerclage<br>Cervical cerclage. | Procedure: Cerclage<br>* Surgical procedure which consists of a strong suture being inserted into and around the cervix to close it.<br>|
| Experimental: Cervical pessary<br>Cervical pessary | Device: Cervical pessary<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous delivery before 34 complete weeks | Spontaneous delivery before 34 complete weeks | Before 34 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous delivery before 28 complete weeks | Spontaneous delivery before 28 complete weeks | Before 28 weeks of gestation | 
| Spontaneous delivery before 37 complete weeks | Spontaneous delivery before 37 complete weeks | Before 37 weeks of gestation | 
| Foetal and neonatal death | Foetal and neonatal death | During pregnancy and during the first 28 days of newborn or NICU stay | 
| Neonatal morbidity | Neonatal morbidity | 28 days of newborn or during NICU stay | 
| Maternal side effects | Maternal side effects | During pregnancy | 
| Maternal morbidity | Maternal morbidity | during pregnancy | 
| Number of participants with chorioamnionitis infection | Number of participants with chorioamnionitis infection | During pregnancy | 
| Hospitalisation for threatened preterm labour | Hospitalisation for threatened preterm labour | During pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical insufficiency, cervical cerclage, cervical pessary