Cerclage vs Cervical Pessary in Women With Cervical Incompetence

Cervical Insufficiency Clinical Trial

— CEPEIC  

Official title:

Cerclage vs Cervical Pessary in Women With Cervical Incompetence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405455
• Other study ID #: CEPEIC
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2021

Study information

• Verified date: March 2021
• Source: Maternal-Infantil Vall d´Hebron Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Insufficiency
• Uterine Cervical Incompetence

Intervention

Procedure:
• Cerclage
Surgical procedure which consists of a strong suture being inserted into and around the cervix to close it.

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.

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Maternal-Infantil Vall d´Hebron Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous delivery before 34 complete weeks	Spontaneous delivery before 34 complete weeks	Before 34 weeks of gestation
Secondary	Spontaneous delivery before 28 complete weeks	Spontaneous delivery before 28 complete weeks	Before 28 weeks of gestation
Secondary	Spontaneous delivery before 37 complete weeks	Spontaneous delivery before 37 complete weeks	Before 37 weeks of gestation
Secondary	Foetal and neonatal death	Foetal and neonatal death	During pregnancy and during the first 28 days of newborn or NICU stay
Secondary	Neonatal morbidity	Neonatal morbidity	28 days of newborn or during NICU stay
Secondary	Maternal side effects	Maternal side effects	During pregnancy
Secondary	Maternal morbidity	Maternal morbidity	during pregnancy
Secondary	Number of participants with chorioamnionitis infection	Number of participants with chorioamnionitis infection	During pregnancy
Secondary	Hospitalisation for threatened preterm labour	Hospitalisation for threatened preterm labour	During pregnancy