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Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features

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ClinicalTrials.gov Identifier: NCT03362450
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Objective:

The small bowel volvulus is a rare cause of intestinal obstruction which may occur in utero and whose prenatal diagnosis is difficult.Sonographic signs are mainly indirect and non specific.The aim of this study is to present a retrospective analysis of prenatal sonographicfindings in fetal segmental midgut volvulus.Thanks to this series the investigators could highlight the more specifics signs of the volvulus included a new pattern.


Condition or disease Intervention/treatment
Fetal Volvulus Midgut Volvulus Other: Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examination

Detailed Description:

Objective:

The small bowel volvulus is a rare cause of intestinal obstruction which may occur in utero and whose prenatal diagnosis is difficult. Sonographic signs are mainly indirect and nonspecific. The aim of this study is to present a retrospective analysis of prenatal sonographic findings in fetal segmental midgut volvulus. Thanks to this series the investigators could highlight the more specifics signs of the volvulus included a new pattern.

Methods:

Unicentric retrospective analysis of cases of prenatal midgut volvulus between 2006 and 2017. The primary inclusion criteria was postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings. The exclusion criteria was the absence of prenatal imaging assessment. The investigators collected the clinical history and the echographic mode B and color Doppler. They have searched for some specific sign like " whirlpool sign " representing the winding of the mesenteric vein around the superior mesenteric arterywith color Doppler with arciform pattern of the midgut, hydro-meconium level in the dilated loops and position of mesenteric vessels for evaluation of the intestinal (mal) rotation. Gold standard was surgery or foetopathology if performed.

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pregnant patients seen for second or third trimester
Foetus with diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings
Other: Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examination
Fetal ultrasound during the second or third trimester Postnatal surgery Post mortem examination




Primary Outcome Measures :
  1. echography [ Time Frame: during the second (22-24 weeks) after ultrasound screening ]
    Observation of specific signs using echography for the diagnosis of fetal during the second (22-24 weeks) and the third (31-34 weeks) trimester after ultrasound screening and when diagnostic ultrasound were performedmidgut volvulus

  2. echography [ Time Frame: the third (31-34 weeks) trimester after ultrasound screening ]
    Observation of specific signs using echography for the diagnosis of fetal


Secondary Outcome Measures :
  1. ultrasound signs of complication [ Time Frame: the third (31-34 weeks) after ultrasound screening ]
    Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.

  2. ultrasound signs of complication [ Time Frame: during the second (22-24 weeks) after ultrasound screening ]
    Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.

  3. ultrasound signs of complication [ Time Frame: 1 day ]
    Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis after diagnostic ultrasound.

  4. ultrasound signs of complication [ Time Frame: just after delivery ]
    Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.

  5. presence or not of the volvulus [ Time Frame: 1 day ]
    Observation of surgery outcome like presence or not of the volvulus after diagnostic ultrasound

  6. presence or not of the volvulus [ Time Frame: during the second (22-24 weeks) after ultrasound screening ]
    Observation of surgery outcome like presence or not of the volvulus

  7. presence or not of the volvulus [ Time Frame: just after delivery ]
    Observation of surgery outcome like presence or not of the volvulus

  8. presence or not of the volvulus [ Time Frame: the third (31-34 weeks) after ultrasound screening ]
    Observation of surgery outcome like presence or not of the volvulus

  9. presence or not ileal atresia. [ Time Frame: during the second (22-24 weeks) after ultrasound screening ]
    Observation of surgery outcome like presence or not ileal atresia

  10. presence or not ileal atresia. [ Time Frame: the third (31-34 weeks) after ultrasound screening ]
    Observation of surgery outcome like presence or not ileal atresia

  11. presence or not ileal atresia. [ Time Frame: just after delivery ]
    Observation of surgery outcome like presence or not ileal atresia

  12. presence or not ileal atresia. [ Time Frame: 1 day ]
    Observation of surgery outcome like presence or not ileal atresia after diagnostic ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All pregnant women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All pregnant women
Criteria

Inclusion Criteria:

  • postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings

Exclusion Criteria:

  • the absence of prenatal imaging assessment

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): NCT03362450


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03362450    
Other Study ID Numbers: RECHMPL17_0321
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Midgut volvulus
Fetal volvulus
Whirlpool sign
Pregnant women
Position of mesenteric vessels
Post natal surgery
Foetopathology if performed
Hydro-meconium level in the dilated loops
Additional relevant MeSH terms:
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Intestinal Volvulus
Digestive System Abnormalities
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Torsion Abnormality
Pathological Conditions, Anatomical
Congenital Abnormalities