Intra-abdominal Umbilical Vein Aneurysm

NCT03653884 | Completed

• 1 other identifier: CHRD0716
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstetric Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (1)

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

Interventions

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.

Pregnancy with fetal intra-abdominal umbilical vein.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patient refusing to participate in the study.

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (1)

Centre Hospitalier René-DUBOS

Cergy-Pontoise, France, 95303, France

Location

Study Officials

• Georges MARKOU

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 31, 2018
• Study Start: January 22, 2018
• Primary Completion: September 14, 2021
• Study Completion: September 14, 2021
• Last Updated: September 19, 2024

Record last verified: 2023-09

Locations

FR (1)