Cerclage vs Cervical Pessary in Women With Cervical Incompetence

NCT ID: NCT02405455

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2021-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cerclage

Cervical cerclage.

Group Type: EXPERIMENTAL

Cerclage

Intervention Type: PROCEDURE

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

Cervical pessary

Cervical pessary

Group Type: EXPERIMENTAL

Cervical pessary

Intervention Type: DEVICE

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.

Interventions

Cerclage

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

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maternal-Infantil Vall d´Hebron Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maria Goya, MD, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Goya, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebrón

Andrea Gascón, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebrón

Locations

Hospital Vall d'Hebron

Barcelona, , Spain

Countries

Spain

Other Identifiers

CEPEIC

Identifier Type: -

Identifier Source: org_study_id