Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

Uhmontpellier

Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03362450
• Other Study ID Numbers: RECHMPL17_0321
• First Posted: December 5, 2017
• Last Update Posted: December 5, 2017
• Last Verified: October 2017

• 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:

Intestinal Volvulus; Digestive System Abnormalities; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Torsion Abnormality; Pathological Conditions, Anatomical; Congenital Abnormalities