A Phase 3 interventional study of Cervical cerclage in Preterm Birth, sponsored by Federico II University. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-03-23.
Sponsored by Federico II University · Phase 3, Interventional, and Treatment
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
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 300 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix
Procedure: Cervical cerclage
No cerclage Women randomized to not receive cerclage represent the control arm
Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)
Spontaneous preterm birth rates <34weeks
Time frame: Less than 34 weeks gestation
Spontaneous preterm birth rates <37, <28 and <24 weeks
Time frame: Less than 24, 28, and 37 weeks gestation
Type of delivery
Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery
Time frame: Time of delivery
Spontaneous rupture of membranes
Ruptured membranes \<34 weeks
Time frame: Less than 34 weeks gestation
Neonatal death
Time frame: Between birth and 28 days of age
birth weight
Time frame: Time of delivery
Chorioamnionitis
histologic diagnosis of chorioamnionitis
Time frame: Time of delivery
necrotizing enterocolitis
Time frame: Between birth and 28 days of age
intraventricular hemorrhage
intraventricular hemorrhage (grade 3 or higher)
Time frame: Between birth and 28 days of age
respiratory distress syndrome
Time frame: Between birth and 28 days of age
bronchopulmonary dysplasia
Time frame: Between birth and 28 days of age
blood-culture proven sepsis
Time frame: Between birth and 28 days of age
neonatal mortality
death of a live-born baby within the first 28 days of life
Time frame: Between birth and 28 days of age
perinatal death
either fetal mortality or neonatal mortality
Time frame: Until 28 days of age
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Federico II University