Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
Gabriele Saccone
Naples, Italy
Spontaneous preterm birth (SPTB) <34 weeks
Spontaneous preterm delivery less than 34 weeks of gestation
Time frame: Less than 34 weeks gestation
SPTB <37w
Time frame: Less than 37 weeks gestation
SPTB <32w
Time frame: Less than 32 weeks gestation
SPTB <28w
Time frame: Less than 32 weeks gestation
Gestational age at delivery
Time frame: Time of delivery
Latency
interval from randomization to delivery in days
Time frame: time of delivery
preterm premature rupture of membranes
Time frame: Less than 34 weeks gestation
Type of delivery
Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery
Time frame: time of delivery
Maternal side effects
Vaginal discharge, bacterial vaginosis
Time frame: Time of delivery
Birth weight
Time frame: Time of delivery
Neonatal death
Time frame: Between birth and 28 days of age
perinatal death
either fetal mortality or neonatal death
Time frame: fetal death after 20 weeks
Composite adverse perinatal outcome
Includes necrotizing enterocolitis, Intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis, and neonatal death
Time frame: Between birth and 28 days of age
Chorioamnionitis
Time frame: Time of delivery
Adminssion to neonatal intensive care unit
Time frame: Between birth and 28 days of age
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