Cervix; Pregnancy, Obstetric Labor Complications, Obstetric Labor, Premature, Pregnancy Complications, Pregnancy, High Risk, Preterm Birth
Conditions
Keywords
ultrasound
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. Other strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix. However, the predictive value of the research has recently been questioned, as the threat rate from preterms in the low-risk population has not decreased over time. Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of cervical softness.
Detailed description
Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its changes during the three trimesters of pregnancy, the evaluation of the cervical consistency index (CCI), or an ultrasound evaluation of cervical softness, was also proposed. Reduced CCI values correspond to greater compressibility and cervical softness. Studies conducted to study cervical remodeling on animal models suggest an early increase in cervical softness that begins immediately after conception followed by shortening and dilation in the terminal stages of pregnancy so that minimal changes in cervicometry correspond to a significant increase in cervical softness . Therefore the study of the early stages of cervical remodeling, such as cervical softness through the ICC, could allow to identify in a timely manner women with an increased risk of preterm birth. The purpose of this study is to define and standardize the transvaginal technique to determine the CCI, its reference range and establish its potential predictive use in the threat of preterm birth before 32, 34 and 37 weeks. The purpose of this study is to verify the hypothesis that the introduction of a universal screening program with TVU CL and CCI measurement, in the three trimesters of pregnancy, may be associated with a predictive ability to deliver preterm higher than current protocols.
Interventions
Cervical lenght and Consistence Cervical Index measurements performed, between 11 and 13 weeks + 6 days, in the , between 19 and 22 weeks and i between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy.
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
This is a prospective, non-pharmacological, non-profit interventional study on women with single pregnancy without a history of previous preterm spontaneous birth. Cervical lenght (CL) and Consistence Cervical Index (CCI) will be assessed by transvaginal ultrasound. CL and CCI measurements will be performed in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during routine ultrasound examinations for monitoring of pregnancy, in accordance with current national guidelines.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Singleton gestations 18-50 years of age
Exclusion criteria
Multiple gestation Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization Labor or cerclage in situ at the time of randomization Women with altered state of consciousness, seriously ill, with mental handicaps;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preterm delivery | Less than 37 weeks gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm birth rates | Less than 24, 28, 34 weeks gestation | — |
| Birth weight | Time of delivery | — |
| Low birth weight | Time of delivery | Birth weight \<2500g |
| Gestational age at delivery | Time of delivery | — |
| Composite adverse neonatal outcome | Between birth and 28 days of age | Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death |
| Admission to neonatal intensive care unit | Between birth and 28 days of age | — |
| Neonatal death | Between birth and 28 days of age | — |
Countries
Italy
Contacts
Primary ContactPasquale De Franciscis, Prof
Backup ContactAntonio Schiattarella, MD
Outcome results
None listed