Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition: an International Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Incidence of cardiac abnormalities found in the first trimester of pregnancy
研究概览
简要总结
Ultrasound is one of the most important tools in pregnancy both for its diagnostic capacity, but also because it is not invasive.
For physiological pregnancy, the Italian guidelines provide for the execution of 3 ultrasounds: one in the first trimester (between 11 and 14 weeks), one in the second trimester (between 20 and 22 weeks) and one in the third (between 30 and 36 weeks). weeks).
Screening for cardiac abnormalities is done during second trimester ultrasound, also called structural ultrasound. However, the development of three-dimensional (3D) sonography has represented a dramatic shift in obstetrics as it allows for the acquisition of a volume of data rather than conventional planar or 2D scans. This method has allowed considerable progress in the study of the fetus in the initial stages of development and has opened new windows in the knowledge of anatomical malformations at an early age.
The possibility of detecting structural anomalies already during the first trimester of pregnancy allows, in fact, to provide the patient with additional time for counseling and for any genetic tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation
排除标准
- •Less than 18 years old
- •Multiple gestations
- •Women with an altered state of consciousness, seriously ill, with mental handicaps;
结局指标
主要结局
Incidence of cardiac abnormalities found in the first trimester of pregnancy
时间窗: Between 11+0 and 13+6 days of pregnancy
Incidence of cardiac abnormalities found in the first trimester of pregnancy by 3D scan
次要结局
- Gestational age at delivery(delivery)
- Preterm birth rates(Less than 24, 28, 34 weeks gestation)
- Birth weight(delivery)
研究者
Antonio Schiattarella
MD
University of Campania "Luigi Vanvitelli"
