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
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Preterm delivery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton gestations 18-50 years of age
排除标准
- •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;
结局指标
主要结局
Preterm delivery
时间窗: Less than 37 weeks gestation
次要结局
- Admission to neonatal intensive care unit(Between birth and 28 days of age)
- Low birth weight(Time of delivery)
- Birth weight(Time of delivery)
- Composite adverse neonatal outcome(Between birth and 28 days of age)
- Gestational age at delivery(Time of delivery)
- Neonatal death(Between birth and 28 days of age)
- Preterm birth rates(Less than 24, 28, 34 weeks gestation)
研究者
Prof. Pasquale De Franciscis
Associate Professor
University of Campania "Luigi Vanvitelli"