Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations. However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
500
Serial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks
Gabriele Saccone
Naples, Italy
RECRUITINGUniversity of Pisa
Pisa, Italy
RECRUITINGPreterm delivery
Time frame: Less than 37 weeks gestation
Gestational age at delivery
Time frame: Time of delivery
preterm birth rates
Time frame: Less than 24, 28, 34 weeks gestation
Birth weight
Time frame: Time of delivery
Low birth weight
Birth weight \<2500g
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
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