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临床试验/NCT03653884
NCT03653884已完成不适用

Intra-abdominal Umbilical Vein Aneurysm

Hôpital NOVO1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Vital status at birth.

研究概览

简要总结

The purpose of this study is to investigate the ultrasound characteristics and outcome of pregnancies with fetal Intra-abdominal umbilical vein aneurysm.

详细描述

Intra-abdominal umbilical vein aneurysm is a rare pathology of the fetal venous system. Its incidence is low, evaluated between 0.4 and 1.1 / 1000.

Intra-abdominal umbilical vein aneurysm is identified as an oval or rounded, anechoic mass located between the abdominal wall and the lower edge of the liver.

It is defined by two criteria: either a diameter greater than 9 mm or a diameter of the subhepatic segment of the umbilical vein greater than 50% of the diameter of its intrahepatic segment.

The complications that can occur during pregnancy are mainly represented by the MFIU, the occurrence of thrombosis and intrauterine growth retardation (IUGR). Their overall frequency is evaluated at 10%.

A complete fetal morphological assessment is necessary to eliminate the presence of other lesions. However, ultrasound monitoring is recommended during the third trimester in search of an increase in dilation and especially the appearance of a thrombus. A particular clinical form, related to abnormal umbilical vein involvement in the infra-hepatic portal system, must be individualized because of a high risk of thrombosis. It justifies the realization of an abdominal ultrasound in the first days of life

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients who have AVO partially intra-abdominal isolated or associated with other abnormalities.
  • Patients over the age of 18 who agree to participate in the study after oral information given by the sonographer.
  • Any patient seen in 1st intention or 2nd intention.
  • Gestational age between 20 and 35 weeks

排除标准

  • Patient refusing to participate in the study.

结局指标

主要结局

Vital status at birth.

时间窗: Through study completion, an average of 2 years.

From birth, it is necessary to evaluate the state of the child. This evaluation is done by the APGAR coefficient. The following actions are systematically performed: place the child on a heating table, aspire mouth, pharynx, nostrils. Specify rapidly, heart and respiratory rhythms, quality of cry, baby's color and responses to skin stimulation. These five criteria rated from zero to two make it possible to determine the Apgar score: it is practiced at one, three, five and ten minutes of life. This assessment helps to guide the behavior of the newborn: if the score is greater than eight to one minute, it means that the newborn has a good adaptation to the ectopic life. If it is less than three to one minute, the newborn is in a state of apparent death involving emergency resuscitation. An intermediate figure, witnessing hypoxia-anoxia, justifies management adapted.

次要结局

  • Collection of congenital anomalies and pregnancy Pathologies.(From the inclusion of the patient until the end of pregnancy.)
  • Characteristics of the umbilical vein aneurysm.(From the inclusion of the patient until the end of pregnancy.)

研究者

发起方
Hôpital NOVO
申办方类型
Other
责任方
Sponsor

研究点 (1)

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