Cervical Insufficiency
Conditions
Keywords
cervical insufficiency, cervical cerclage, cervical pessary
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.
Interventions
PROCEDURECerclage
Surgical procedure which consists of a strong suture being inserted into and around the cervix to close it.
DEVICECervical 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.
Sponsors
Maternal-Infantil Vall d´Hebron Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cervical pessary vs. Cervical cerclage
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous delivery before 34 complete weeks | Before 34 weeks of gestation | Spontaneous delivery before 34 complete weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous delivery before 28 complete weeks | Before 28 weeks of gestation | Spontaneous delivery before 28 complete weeks |
| Spontaneous delivery before 37 complete weeks | Before 37 weeks of gestation | Spontaneous delivery before 37 complete weeks |
| Foetal and neonatal death | During pregnancy and during the first 28 days of newborn or NICU stay | Foetal and neonatal death |
| Neonatal morbidity | 28 days of newborn or during NICU stay | Neonatal morbidity |
| Maternal side effects | During pregnancy | Maternal side effects |
| Maternal morbidity | during pregnancy | Maternal morbidity |
| Number of participants with chorioamnionitis infection | During pregnancy | Number of participants with chorioamnionitis infection |
| Hospitalisation for threatened preterm labour | During pregnancy | Hospitalisation for threatened preterm labour |
Countries
Spain
Outcome results
None listed