Preterm Birth
Conditions
Brief summary
Preterm birth (PTB) is a 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, we aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy without prior spontaneous PTB
Interventions
OTHERTVU CL screening
Transvaginal ultrasound cervical length screening
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18-50 years of age * Singleton pregnancy (limits the participants to female gender) * No prior spontaneous preterm delivery, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks
Exclusion criteria
* Multiple gestation * Prior spontaneous preterm birth 16-36 6/7 weeks * Ruptured membranes at time of randomization * Lethal fetal structural anomaly at time of randomization * Fetal chromosomal abnormality at time of randomization * Placenta previa and/or accreta at time of randomization * Women who already underwent TVU CL measurement during the index pregnancy
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 |
|---|---|---|
| preterm birth rates | Less than 24, 28, 32, 30, and 34 weeks gestation | either spontaneous or indicated preterm delivery |
| admission to neonatal intensive care unit | time of delivery | — |
| Composite perinatal outcome | Between birth and 28 days of age | Includes 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 |
| necrotizing enterocolitis | Between birth and 28 days of age | Defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation |
| intraventricular hemorrhage (grade 3 or higher) | Between birth and 28 days of age | IVH |
| Perinatal death | Between birth and 28 days of age | either neonatal death or fetal death |
| birth weight | time of delivery | — |
| Length of hospital stay | Discharge from hospital | Days in NICU |
| Neonatal death | Between birth and 28 days of age | — |
| gestational age at delivery | time of delivery | — |
| latency | time of delivery | from randomization to delivery |
| respiratory distress syndrome | Time of delivery | Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates |
Countries
Italy
Outcome results
None listed