Intestinal MalrotationVOLMESNCT03356314
Prenatal Ultrasound Screening of Intestinal Malrotation With a Higher Risk of Volvulus
An observational study of Intestinal Malrotation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study was to assess the value of an unusual relative position of the superior mesenteric artery (SMA) and vein (SMV) to screen intestinal malrotation with a higher risk of volvulus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intestinal Malrotation
- What is being tested?
- MRI between 30-35 GA, Pediatric surgeon meeting and Postnatal abdominal ultrasound, barium enema and upper gastrointestinal
- How many people
- 9,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All pregnant women
Who may be able to join
- pregnant women
- second or third trimester ultrasound.
Who cannot join
- fœtal ultrasound anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prenatal Ultrasound Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of The Relative Position of The Superior Mesenteric Artery and Vein. Future of the Children With an Antenatal Malrotation Suspicion
The aim of this study was to assess the value of an unusual relative position of the superior mesenteric artery (SMA) and vein (SMV) to screen intestinal malrotation with a higher risk of volvulus.
First, feasibility study was done to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.
Read more
A systematic screening of the mesenteric vessels position was performed at each pregnancy required ultrasound.
When the fœtus had an unusual position of the mesenteric vessels, an MRI was suggested between 30 and 35 GA and the couple met the pediatric surgery team.
Few days after birth, an abdominal ultrasound was achieved as well as a barium enema and upper gastrointestinal. If there were a hight probability of malrotation with a higher risk of volvulus, a prophylactic surgery was proposed. The children were flollowed up during 1 year.
- Conditions
- Intestinal Malrotation
- Being tested
- MRI between 30-35 GA, Pediatric surgeon meeting, Postnatal abdominal ultrasound, barium enema and upper gastrointestinal, +/- prophylactic surgery
- Keywords
- superior mesenteric artery, superior mesenteric vein, intestinal malrotation, volvulus, pregnant women, mesenteric vessels position, postnatal diagnosis, prophylactic surgery
- Medical subject headings
- Volvulus Of Midgut, Intestinal Volvulus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI between 30-35 GAOther
MRI between 30-35 GA
Pediatric surgeon meetingOther
Pediatric surgeon meeting
Postnatal abdominal ultrasound, barium enema and upper gastrointestinalOther
Postnatal abdominal ultrasound, barium enema and upper gastrointestinal
+/- prophylactic surgeryOther
+/- prophylactic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of ultrasound in the diagnosis of the abnormal position of the mesenteric vessels
Feasibility study to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.
Measured: 1 day (Pre and post natal ultrasound)
Antenatal screening of intestinal malrotation
Antenatal screening of intestinal malrotation with higher risk of volvulus.
Measured: 1 day (Pre and post natal ultrasound)
Future of the children with an ante natal diagnosis of intestinal malrotation
Future of the children with an ante natal diagnosis of intestinal malrotation
Measured: 1 year after birth
Secondary outcomes (2)
Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.
Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.
Measured: 1 day (During Pregnancy)
Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.
Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.
Measured: 1 day (after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Jan 2017
- Primary completion1 May 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal MalrotationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- florent FUCHS, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356314
- Sponsor's protocol ID
- RECHMPL17_0258
- Acronym
- VOLMES
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Ultrasound Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of The Relative Position of The Superior Mesenteric Artery and Vein. Future of the Children With an Antenatal Malrotation Suspicion
- ClinicalTrials.gov ID
- NCT03356314
- Acronym / sponsor ID
- VOLMES / RECHMPL17_0258
- Conditions
- Intestinal Malrotation
- Keywords
- superior mesenteric artery, superior mesenteric vein, intestinal malrotation, volvulus, pregnant women, mesenteric vessels position, postnatal diagnosis, prophylactic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to assess the value of an unusual relative position of the superior mesenteric artery (SMA) and vein (SMV) to screen intestinal malrotation with a higher risk of volvulus.
First, feasibility study was done to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.
A systematic screening of the mesenteric vessels position was performed at each pregnancy required ultrasound.
When the fœtus had an unusual position of the mesenteric vessels, an MRI was suggested between 30 and 35 GA and the couple met the pediatric surgery team.
Few days after birth, an abdominal ultrasound was achieved as well as a barium enema and upper gastrointestinal. If there were a hight probability of malrotation with a higher risk of volvulus, a prophylactic surgery was proposed. The children were flollowed up during 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women
Key inclusion criteria (2 listed)
- pregnant women
- second or third trimester ultrasound.
Key exclusion criteria (1 listed)
- fœtal ultrasound anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI between 30-35 GAMRI between 30-35 GA | Other | – |
| Pediatric surgeon meetingPediatric surgeon meeting | Other | – |
| Postnatal abdominal ultrasound, barium enema and upper gastrointestinalPostnatal abdominal ultrasound, barium enema and upper gastrointestinal | Other | – |
| +/- prophylactic surgery+/- prophylactic surgery | Other | – |
Primary outcome
Reproducibility of ultrasound in the diagnosis of the abnormal position of the mesenteric vessels
Time frame: 1 day (Pre and post natal ultrasound)
Feasibility study to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.
Antenatal screening of intestinal malrotation
Time frame: 1 day (Pre and post natal ultrasound)
Antenatal screening of intestinal malrotation with higher risk of volvulus.
Future of the children with an ante natal diagnosis of intestinal malrotation
Time frame: 1 year after birth
Future of the children with an ante natal diagnosis of intestinal malrotation
2 secondary outcomes
Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.
Time frame: 1 day (During Pregnancy)
Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.
Time frame: 1 day (after delivery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: Undecided. NC
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Gastrointestinal Complication, Intestinal Obstruction
Not yet recruitingObservational study
Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
florent FUCHS principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Malrotation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of ultrasound in the diagnosis of the abnormal position of the mesenteric vessels (time frame: 1 day (Pre and post natal ultrasound)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.