Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth

Study Overview
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Brief Summary
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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

Official Title
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Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth

Conditions
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Preterm Birth

Intervention / Treatment
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* Other: TVU CL screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TVU CL screening<br>TVU CL screening: single TVU CL at 18 0/7 to 23 6/7 every week | Other: TVU CL screening<br>* Transvaginal ultrasound cervical length screening<br>|
| No Intervention: no screening<br>no TVU CL screening | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm birth rate | either spontaneous or indicated preterm delivery | Less than 37 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal death | either neonatal death or fetal death | Between birth and 28 days of age | 
| preterm birth rates | either spontaneous or indicated preterm delivery | Less than 24, 28, 32, 30, and 34 weeks gestation | 
| admission to neonatal intensive care unit |  | time of delivery | 
| Composite perinatal outcome | 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 | Between birth and 28 days of age | 
| necrotizing enterocolitis | 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 | Between birth and 28 days of age | 
| intraventricular hemorrhage (grade 3 or higher) | IVH | Between birth and 28 days of age | 
| respiratory distress syndrome | Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates | Time of delivery | 
| birth weight |  | time of delivery | 
| Length of hospital stay | Days in NICU | Discharge from hospital | 
| Neonatal death |  | Between birth and 28 days of age | 
| gestational age at delivery |  | time of delivery | 
| latency | from randomization to delivery | time of delivery |