- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362450
Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Uhmontpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings
Exclusion Criteria:
- the absence of prenatal imaging assessment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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
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Fetal ultrasound during the second or third trimester Postnatal surgery Post mortem examination
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
echography
Time Frame: during the second (22-24 weeks) after ultrasound screening
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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
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during the second (22-24 weeks) after ultrasound screening
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echography
Time Frame: the third (31-34 weeks) trimester after ultrasound screening
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Observation of specific signs using echography for the diagnosis of fetal
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the third (31-34 weeks) trimester after ultrasound screening
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ultrasound signs of complication
Time Frame: the third (31-34 weeks) after ultrasound screening
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Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.
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the third (31-34 weeks) after ultrasound screening
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ultrasound signs of complication
Time Frame: during the second (22-24 weeks) after ultrasound screening
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Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.
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during the second (22-24 weeks) after ultrasound screening
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ultrasound signs of complication
Time Frame: 1 day
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Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis after diagnostic ultrasound.
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1 day
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ultrasound signs of complication
Time Frame: just after delivery
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Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.
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just after delivery
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presence or not of the volvulus
Time Frame: 1 day
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Observation of surgery outcome like presence or not of the volvulus after diagnostic ultrasound
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1 day
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presence or not of the volvulus
Time Frame: during the second (22-24 weeks) after ultrasound screening
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Observation of surgery outcome like presence or not of the volvulus
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during the second (22-24 weeks) after ultrasound screening
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presence or not of the volvulus
Time Frame: just after delivery
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Observation of surgery outcome like presence or not of the volvulus
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just after delivery
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presence or not of the volvulus
Time Frame: the third (31-34 weeks) after ultrasound screening
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Observation of surgery outcome like presence or not of the volvulus
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the third (31-34 weeks) after ultrasound screening
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presence or not ileal atresia.
Time Frame: during the second (22-24 weeks) after ultrasound screening
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Observation of surgery outcome like presence or not ileal atresia
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during the second (22-24 weeks) after ultrasound screening
|
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
|
the third (31-34 weeks) after ultrasound screening
|
presence or not ileal atresia.
Time Frame: just after delivery
|
Observation of surgery outcome like presence or not ileal atresia
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just after delivery
|
presence or not ileal atresia.
Time Frame: 1 day
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Observation of surgery outcome like presence or not ileal atresia after diagnostic ultrasound
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1 day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL17_0321
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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