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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03362450
Other study ID # RECHMPL17_0321
Secondary ID
Status Completed
Phase N/A
First received October 25, 2017
Last updated December 4, 2017
Start date January 1, 2006
Est. completion date September 30, 2017

Study information

Verified date October 2017
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date September 30, 2017
Est. primary completion date July 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary echography 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 during the second (22-24 weeks) after ultrasound screening
Primary echography Observation of specific signs using echography for the diagnosis of fetal the third (31-34 weeks) trimester after ultrasound screening
Secondary ultrasound signs of complication Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis. the third (31-34 weeks) after ultrasound screening
Secondary ultrasound signs of complication Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis. during the second (22-24 weeks) after ultrasound screening
Secondary ultrasound signs of complication Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis after diagnostic ultrasound. 1 day
Secondary ultrasound signs of complication Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis. just after delivery
Secondary presence or not of the volvulus Observation of surgery outcome like presence or not of the volvulus after diagnostic ultrasound 1 day
Secondary presence or not of the volvulus Observation of surgery outcome like presence or not of the volvulus during the second (22-24 weeks) after ultrasound screening
Secondary presence or not of the volvulus Observation of surgery outcome like presence or not of the volvulus just after delivery
Secondary presence or not of the volvulus Observation of surgery outcome like presence or not of the volvulus the third (31-34 weeks) after ultrasound screening
Secondary presence or not ileal atresia. Observation of surgery outcome like presence or not ileal atresia during the second (22-24 weeks) after ultrasound screening
Secondary presence or not ileal atresia. Observation of surgery outcome like presence or not ileal atresia the third (31-34 weeks) after ultrasound screening
Secondary presence or not ileal atresia. Observation of surgery outcome like presence or not ileal atresia just after delivery
Secondary presence or not ileal atresia. Observation of surgery outcome like presence or not ileal atresia after diagnostic ultrasound 1 day
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