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

NCT05148429 | Completed

• 1 other identifier: RECHMPL21_0684
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postnatal Complication; Mesenteric Pregnancy

Keywords

Pregnant women; 2nd trimester ultrasound examination; Mesenteric vessels positionning; Pediatric follow up +/- treatment; Postnatal confirmation; Evolution and complication

Outcome Measures

Primary Outcomes (1)

• Percentage of intestinal malrotation among foetuses

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

  day 1

Secondary Outcomes (3)

• Rate of correlation between prenatal

  day 1

• Rate of postnatal ultrasound

  day 1

• type of intestinal malrotation

  day 1

Study Arms (1)

Fetuses with abnormal positionning of mesenteric vessels

All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan

Other: Ultrasound exam; Other: Fetal MRI; Other: Postnatal abdominal ultrasound; Other: Pediatric Follow up

Interventions

Ultrasound exam OTHER

Ultrasound exam

Fetuses with abnormal positionning of mesenteric vessels

Fetal MRI OTHER

Fetal MRI

Fetuses with abnormal positionning of mesenteric vessels

Postnatal abdominal ultrasound OTHER

Postnatal abdominal ultrasound

Fetuses with abnormal positionning of mesenteric vessels

Pediatric Follow up OTHER

Pediatric Follow up

Fetuses with abnormal positionning of mesenteric vessels

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women attending for 2nd trimester scan

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

• Florent FUCHS, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: January 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-11

Locations

FR (1)