Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transvaginal ultrasound cervical length screening.
- Who it may be relevant to
- Registry conditions: Preterm Birth. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Other Transvaginal ultrasound cervical length screening
Serial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks
Primary outcome measures
- Preterm delivery [Time frame: Less than 37 weeks gestation]
Secondary outcome measures (7)
- Gestational age at delivery [Time frame: Time of delivery]
- preterm birth rates [Time frame: Less than 24, 28, 34 weeks gestation]
- Birth weight [Time frame: Time of delivery]
- Low birth weight [Time frame: Time of delivery]
- Neonatal death [Time frame: Between birth and 28 days of age]
- Composite adverse neonatal outcome [Time frame: Between birth and 28 days of age]
- Admission to neonatal intensive care unit [Time frame: Between birth and 28 days of age]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 2 centers
- Gabriele Saccone — Naples
- University of Pisa — Pisa
Identifiers
NCT: NCT02923973 · #30/18