Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

Phase 3

• Conditions: Preterm Birth
• Interventions: Procedure: Cervical cerclage

• Registration Number: NCT02716922
• Lead Sponsor: Federico II University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-17
• Study First Posted: 2016-03-23
• Last Update Posted: 2016-03-23
• Primary Completion: 2018-04
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical cerclage	Cervical cerclage	Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix

Primary Outcome Measures

Name	Time	Method
Spontaneous preterm birth rates <34weeks	Less than 34 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Type of delivery	Time of delivery	Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery
intraventricular hemorrhage	Between birth and 28 days of age	intraventricular hemorrhage (grade 3 or higher)
Spontaneous rupture of membranes	Less than 34 weeks gestation	Ruptured membranes \<34 weeks
Neonatal death	Between birth and 28 days of age
birth weight	Time of delivery
Chorioamnionitis	Time of delivery	histologic diagnosis of chorioamnionitis
perinatal death	Until 28 days of age	either fetal mortality or neonatal mortality
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	death of a live-born baby within the first 28 days of life

Trial Locations

Locations (1)

Gabriele Saccone; 🇮🇹 Napoli, Italy