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Completed

NCT Number: NCT05148429

Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus.

Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.

The aim of the study is to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels

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Key information

Conditions

Postnatal Complication Mesenteric Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women attending for 2nd trimester ultrasound
  • Abnormal positionning of mesenteric vessels
  • No other foetal malformation
  • Singleton pregnancy
  • Age >18 years

Exclusion criteria

  • Chromosomal abnormality
  • polymalformative syndrom
  • Foetal malformation changing intestine disposition (gastroschisis, diaphragmatic hernia, heterotaxis…)

Treatment and study plan

Ultrasound exam

Other

Ultrasound exam

Fetal MRI

Other

Fetal MRI

Postnatal abdominal ultrasound

Other

Postnatal abdominal ultrasound

Pediatric Follow up

Other

Pediatric Follow up

Primary outcomes

  1. Percentage of intestinal malrotation among foetuses

    Time frame: day 1

    Percentage of intestinal malrotation among foetuses with abnormal positionning of mesenteric vessels

Secondary outcomes

  1. Rate of correlation between prenatal

    Time frame: day 1

    Rate of correlation between prenatal

  2. Rate of postnatal ultrasound

    Time frame: day 1

    Rate of postnatal ultrasound

  3. type of intestinal malrotation

    Time frame: day 1

    type of intestinal malrotation

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of the Ultrasound Study of the Relative Position of the Superior Mesenteric Vessels and Fetal Abdominal MRI.

Acronym: MALROT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2021
Registry last updated
Dec 23, 2021

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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