Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- preterm birth rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
preterm birth rate
Time Frame: Less than 37 weeks
either spontaneous or indicated preterm delivery
Secondary Outcomes
- Neonatal death(Between birth and 28 days of age)
- intraventricular hemorrhage (grade 3 or higher)(Between birth and 28 days of age)
- necrotizing enterocolitis(Between birth and 28 days of age)
- Perinatal death(Between birth and 28 days of age)
- gestational age at delivery(time of delivery)
- latency(time of delivery)
- admission to neonatal intensive care unit(time of delivery)
- preterm birth rates(Less than 24, 28, 32, 30, and 34 weeks gestation)
- Composite perinatal outcome(Between birth and 28 days of age)
- Length of hospital stay(Discharge from hospital)
- respiratory distress syndrome(Time of delivery)
- birth weight(time of delivery)
Investigators
Gabriele Saccone
MD
Federico II University