The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. Multiple gestations, including triplets, account for about 3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very low birth weight infants, and nearly 20% of infant mortality. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a short CL \<25mm before 24weeks, cerclage is associated with significant decreases in PTB and perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the contrary, the effect of cerclage in multiple gesttations has been insufficiently studied, with meta-analysis data showing a possible harm from cerclage compared to controls. The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in unselected triplet gestations. We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU CL \<30 mm)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Gabriele Saccone
Naples, Italy
Preterm delivery
Time frame: Less than 34 weeks gestation
Gestational age at delivery
Time frame: Time of delivery
Birth weight
Time frame: Time of delivery
pontaneous preterm birth rates
Time frame: Less than 24, 28, 34 and 37 weeks gestation
Spontaneous rupture of membranes
Time frame: Less than 34 weeks gestation
Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery
Time frame: Time of delivery
Neonatal death
Time frame: Between birth and 28 days of age
Composite adverse neonatal 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
Admission to neonatal intensive care unit
Time frame: Between birth and 28 days of age
Chorioamnionitis
Time frame: Time of delivery
Significant adverse maternal effects
Includes heavy bleeding, injury (eg erosion; fistula; etc) to vagina; injury (eg erosion; fistula; etc) to bladder, cervical tear and uterine rupture
Time frame: Time of delivery
Intolerance to pessary
Defined as request for removal secondary to discomfort and/or discharge
Time frame: Prior to delivery
Preterm delivery
Time frame: Less than 24, 28 and 37 weeks
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