Clinical trial NCT02405455: Cerclage vs Cervical Pessary in Women With Cervical Incompetence
Official title: Cerclage vs Cervical Pessary in Women With Cervical Incompetence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Insufficiency
Keywords: cervical insufficiency
cervical cerclage
cervical pessary
Lead sponsor: Maternal-Infantil Vall d´Hebron Hospital
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cervical pessary vs. Cervical cerclage
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Spontaneous delivery before 34 complete weeks
timeFrame: Before 34 weeks of gestation
Secondary outcomes:
measure: Spontaneous delivery before 28 complete weeks
timeFrame: Before 28 weeks of gestation
measure: Spontaneous delivery before 37 complete weeks
timeFrame: Before 37 weeks of gestation
measure: Foetal and neonatal death
timeFrame: During pregnancy and during the first 28 days of newborn or NICU stay
measure: Neonatal morbidity
timeFrame: 28 days of newborn or during NICU stay
measure: Maternal side effects
timeFrame: During pregnancy
measure: Maternal morbidity
timeFrame: during pregnancy
measure: Number of participants with chorioamnionitis infection
timeFrame: During pregnancy
measure: Hospitalisation for threatened preterm labour
timeFrame: During pregnancy
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebrón
name: Maria Goya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d'Hebrón
name: Andrea Gascón, MD
role: PRINCIPAL_INVESTIGATOR
References: