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Completed

NCT Number: NCT03653884

Intra-abdominal Umbilical Vein Aneurysm

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

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Key information

Conditions

Obstetric Complication

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier René-DUBOS

Cergy-Pontoise, France, 95303

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound monitoring

Diagnostic Test

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.

Primary outcomes

  1. Vital status at birth.

    Time frame: 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.

Secondary outcomes

  1. Collection of congenital anomalies and pregnancy Pathologies.

    Time frame: From the inclusion of the patient until the end of pregnancy.

    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.

  2. Characteristics of the umbilical vein aneurysm.

    Time frame: From the inclusion of the patient until the end of pregnancy.

    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).

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Acronym: AVO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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