Preterm Birth Clinical Trial
— PreBirthCervOfficial title:
Prevention of Preterm Birth by Universal Screening With Ultrasound Measurement of the Consistency Index and Length of the Uterine Cervix in Women With a Single
NCT number | NCT04444206 |
Other study ID # | 8451 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 25, 2020 |
Est. completion date | December 30, 2022 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 30, 2022 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
Italy | University of Campania "Luigi Vanvitelli" | Naples |
Lead Sponsor | Collaborator |
---|---|
University of Campania "Luigi Vanvitelli" |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preterm delivery | Less than 37 weeks gestation | ||
Secondary | Gestational age at delivery | Time of delivery | ||
Secondary | Preterm birth rates | Less than 24, 28, 34 weeks gestation | ||
Secondary | Birth weight | Time of delivery | ||
Secondary | Low birth weight | Birth weight <2500g | Time of delivery | |
Secondary | Neonatal death | Between birth and 28 days of age | ||
Secondary | Composite adverse neonatal outcome | Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death | Between birth and 28 days of age | |
Secondary | Admission to neonatal intensive care unit | Between birth and 28 days of age |
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