NCT02405455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

5.8 years

First QC Date

March 16, 2015

Last Update Submit

March 16, 2021

Conditions

Cervical Insufficiency

Keywords

cervical insufficiencycervical cerclagecervical pessary

Outcome Measures

Primary Outcomes (1)

  • Spontaneous delivery before 34 complete weeks

    Spontaneous delivery before 34 complete weeks

    Before 34 weeks of gestation

Secondary Outcomes (8)

  • Spontaneous delivery before 28 complete weeks

    Before 28 weeks of gestation

  • Spontaneous delivery before 37 complete weeks

    Before 37 weeks of gestation

  • Foetal and neonatal death

    During pregnancy and during the first 28 days of newborn or NICU stay

  • Neonatal morbidity

    28 days of newborn or during NICU stay

  • Maternal side effects

    During pregnancy

  • +3 more secondary outcomes

Study Arms (2)

Cerclage

EXPERIMENTAL

Cervical cerclage.

Procedure: Cerclage

Cervical pessary

EXPERIMENTAL

Cervical pessary

Device: Cervical pessary

Interventions

CerclagePROCEDURE

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

Cerclage
Cervical pessaryDEVICE

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.

Cervical pessary

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Uterine Cervical Incompetence

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Uterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAbortion, HabitualAbortion, SpontaneousPregnancy ComplicationsGenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Maria Goya, PhD

    Hospital Vall d'Hebrón

    PRINCIPAL INVESTIGATOR

  • Andrea Gascón, MD

    Hospital Vall d'Hebrón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cervical pessary vs. Cervical cerclage
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 16, 2015

First Posted

April 1, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

ES(1)