NCT02716922UnknownPhase 3
Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth
Federico II University2 sites in 1 country300 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Spontaneous preterm birth rates <34weeks
Study Overview
Brief Summary
Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Singleton pregnancy (limits the participants to female gender)
- •Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
- •18-50 years of age
Exclusion Criteria
- •Multiple gestation
- •Prior spontaneous preterm birth 16-36 6/7 weeks
- •Ruptured membranes
- •Lethal fetal structural anomaly
- •Fetal chromosomal abnormality
- •Pessary in place (or planned placement)
- •Vaginal bleeding
- •Suspicion of chorioamnionitis
- •Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
- •Painful regular uterine contractions
- •Placenta previa
Outcomes
Primary Outcomes
Spontaneous preterm birth rates <34weeks
Time Frame: Less than 34 weeks gestation
Secondary Outcomes
- Type of delivery(Time of delivery)
- intraventricular hemorrhage(Between birth and 28 days of age)
- Spontaneous rupture of membranes(Less than 34 weeks gestation)
- Neonatal death(Between birth and 28 days of age)
- birth weight(Time of delivery)
- Chorioamnionitis(Time of delivery)
- perinatal death(Until 28 days of age)
- Spontaneous preterm birth rates <37, <28 and <24 weeks(Less than 24, 28, and 37 weeks gestation)
- necrotizing enterocolitis(Between birth and 28 days of age)
- respiratory distress syndrome(Between birth and 28 days of age)
- bronchopulmonary dysplasia(Between birth and 28 days of age)
- blood-culture proven sepsis(Between birth and 28 days of age)
- neonatal mortality(Between birth and 28 days of age)
Investigators
Gabriele Saccone
Medical Doctor
Federico II University
Study Sites (2)
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