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Intra-abdominal Umbilical Vein Aneurysm (AVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653884
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier René Dubos

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

Condition or disease Intervention/treatment
Obstetric Complication Diagnostic Test: Ultrasound monitoring

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intra-abdominal Umbilical Vein Aneurysm
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : June 22, 2020
Estimated Study Completion Date : December 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Group/Cohort Intervention/treatment
Pregnancy with fetal intra-abdominal umbilical vein.
All women with a pregnancy with a partially intra-abdominal umbilical vein aneurysm isolated or associated with other abnormalities découvert lors d'une ultrasonic monitoring.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653884


Contacts
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Contact: Georges MARKOU, MD 0033660777190 georgesmarkou@hotmail.com
Contact: Véronique DA COSTA 331.30.75.50.69 veronique.dacosta@ght-novo.fr

Locations
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France
Centre Hospitalier René-DUBOS Recruiting
Cergy-Pontoise, France, 95303
Contact: Georges MARKOU    0033660777190    georgesmarkou@hotmail.com   
Contact: Sandrine GOULVENT    331.30.75.40.40 (Post 7241)    sandrine.goulvent@ght-novo.fr   
Sponsors and Collaborators
Centre Hospitalier René Dubos
Investigators
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Principal Investigator: Georges MARKOU Centre Hospitalier René Dubos

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Responsible Party: Centre Hospitalier René Dubos
ClinicalTrials.gov Identifier: NCT03653884    
Other Study ID Numbers: CHRD0716
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases