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临床试验/NCT05666297
NCT05666297尚未招募不适用

Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition: an International Multicenter Study

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2022年12月20日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Schiattarella

MD

University of Campania "Luigi Vanvitelli"

研究点 (1)

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