Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

Federico II University300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Preterm Birth

Interventions

Cervical cerclagePROCEDURE

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)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Gabriele Saccone

Napoli, Italy

RECRUITING

Outcomes

Primary Outcomes

Spontaneous preterm birth rates <34weeks

Time frame: Less than 34 weeks gestation

Secondary Outcomes

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

Data from ClinicalTrials.gov

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