Preterm Birth
Conditions
Brief summary
This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.
Interventions
DIAGNOSTIC_TESTcervical length screening
transvaginal ultrasound cervical length
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
are: * Singleton gestations * No prior SPTB
Exclusion criteria
are: * Multiple gestations * History of SPTB in a prior pregnancy * Rupture of membranes at the time of randomization * Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality * Fetal death at the time of randomization * Cerclage in situ at the time of randomization * Pessary in situ at the time of randomization * Vaginal bleeding at the time of randomization * Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| preterm birth rate | Less than 37 weeks | either spontaneous or indicated preterm delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| admission to neonatal intensive care unit | time of delivery | — |
| neonatal death | Between birth and 28 days of age | — |
| preterm birth rate | ess than 24, 28, 32, 30, and 34 weeks gestation | either spontaneous or indicated preterm delivery |
| Composite of adverse perinatal outcomes | Between birth and 28 days of age | Number of neonates who will have at least one of the following: necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) (grade 3 or higher), respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), retinopathy (ROP), blood-culture proven sepsis and neonatal death |
| perinatal death | Between birth and 28 days of age | either fetal or neonatal mortality |
| birth weight | time of delivery | weight of the baby at the time of delivery |
Countries
Italy
Outcome results
None listed