Intra-abdominal Umbilical Vein Aneurysm

Obstetric Complication Clinical Trial

— AVO  

Official title:

Intra-abdominal Umbilical Vein Aneurysm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653884
• Other study ID #: CHRD0716
• Status: Completed
• Start date: January 22, 2018
• Est. completion date: September 14, 2021

Study information

• Verified date: September 2023
• Source: Hôpital NOVO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Obstetric Complication

Intervention

Diagnostic Test:
• Ultrasound monitoring
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. This is an aneurysm of the umbilical vein when the umbilical vein has 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.

Locations

Country	Name	City	State
France	Centre Hospitalier René-DUBOS	Cergy-Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital status at birth.	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.	Through study completion, an average of 2 years.
Secondary	Collection of congenital anomalies and pregnancy Pathologies.	The complications that may occur during pregnancy are mainly an MFIU, the occurrence of thrombosis and intrauterine growth retardation (IUGR). 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 nicking 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.	From the inclusion of the patient until the end of pregnancy.
Secondary	Characteristics of the umbilical vein aneurysm.	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. There are two forms: an isolated form and a form with other associated abnormalities, which accounts for 29-35% of cases (cardiovascular anomalies, urogenital and hydramnios). Chromosomal abnormalities are found in 6% of cases (T21, T18, T9, triploidy (28% for associated forms and 2% for isolated forms).	From the inclusion of the patient until the end of pregnancy.