Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 3
- Primary Endpoint
- Preterm delivery
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-50 years of age
- •Singleton gestations
- •Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks
Exclusion Criteria
- •multiple gestation
- •Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization
- •Ballooning of membranes outside the cervix into the vagina at the time of randomization
- •Labor or cerclage in situ at the time of randomization
Outcomes
Primary Outcomes
Preterm delivery
Time Frame: Less than 37 weeks gestation
Secondary Outcomes
- Neonatal death(Between birth and 28 days of age)
- Low birth weight(Time of delivery)
- Composite adverse neonatal outcome(Between birth and 28 days of age)
- Admission to neonatal intensive care unit(Between birth and 28 days of age)
- Gestational age at delivery(Time of delivery)
- preterm birth rates(Less than 24, 28, 34 weeks gestation)
- Birth weight(Time of delivery)
Investigators
Gabriele Saccone
MD
Federico II University