Clinical trial NCT03653884: Intra-abdominal Umbilical Vein Aneurysm
Official title: Intra-abdominal Umbilical Vein Aneurysm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Complication
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient refusing to participate in the study.

Primary outcomes:
measure: Vital status at birth.
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Collection of congenital anomalies and pregnancy Pathologies.
timeFrame: From the inclusion of the patient until the end of pregnancy.
measure: Characteristics of the umbilical vein aneurysm.
timeFrame: From the inclusion of the patient until the end of pregnancy.
Other outcomes:
Locations:
city: Cergy-Pontoise
country: France
facility: Centre Hospitalier René-DUBOS
Study officials:
affiliation: Hôpital NOVO
name: Georges MARKOU
role: PRINCIPAL_INVESTIGATOR
References: