Cerclage vs Cervical Pessary in Women With Cervical Incompetence (CEPEIC)

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.

Study Overview

• Status: Completed
• Conditions: Cervical Insufficiency
• Intervention / Treatment: Procedure: Cerclage; Device: Cervical pessary

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Experimental: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maternal-Infantil Vall d´Hebron Hospital
• Investigators: Principal Investigator: Maria Goya, PhD, Hospital Vall d'Hebron; Principal Investigator: Andrea Gascón, MD, Hospital Vall d'Hebron

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): April 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: cervical pessary; cervical insufficiency; cervical cerclage
• Additional Relevant MeSH Terms: Uterine Cervical Diseases; Uterine Diseases; Pregnancy Complications; Abortion, Habitual; Abortion, Spontaneous; Uterine Cervical Incompetence
• Other Study ID Numbers: CEPEIC