Postnatal ComplicationMALROTNCT05148429
Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus.
An observational study of Postnatal Complication and Mesenteric Pregnancy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postnatal Complication, Mesenteric Pregnancy
- What is being tested?
- Ultrasound exam, Fetal MRI and Postnatal abdominal ultrasound
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Nov 2021
- 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: Pregnant women attending for 2nd trimester scan
Who may be able to join
- Pregnant women attending for 2nd trimester ultrasound
- Abnormal positionning of mesenteric vessels
- No other foetal malformation
- Singleton pregnancy
- Age >18 years
Who cannot join
- Chromosomal abnormality
- polymalformative syndrom
- Foetal malformation changing intestine disposition (gastroschisis, diaphragmatic hernia, heterotaxis…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of the Ultrasound Study of the Relative Position of the Superior Mesenteric Vessels and Fetal Abdominal MRI.
Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.
The aim of the study is to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels
- Conditions
- Postnatal Complication, Mesenteric Pregnancy
- Being tested
- Ultrasound exam, Fetal MRI, Postnatal abdominal ultrasound, Pediatric Follow up
- Keywords
- Pregnant women, 2nd trimester ultrasound examination, Mesenteric vessels positionning, Pediatric follow up +/- treatment, Postnatal confirmation, Evolution and complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examOther
Ultrasound exam
Fetal MRIOther
Fetal MRI
Postnatal abdominal ultrasoundOther
Postnatal abdominal ultrasound
Pediatric Follow upOther
Pediatric Follow up
| Study group | Role | What they receive |
|---|---|---|
| Fetuses with abnormal positionning of mesenteric vessels | All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan Receives: Other: Ultrasound exam; Other: Fetal MRI; Other: Postnatal abdominal ultrasound; Other: Pediatric Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of intestinal malrotation among foetuses
Percentage of intestinal malrotation among foetuses with abnormal positionning of mesenteric vessels
Measured: day 1
Secondary outcomes (3)
Rate of correlation between prenatal
Rate of correlation between prenatal
Measured: day 1
Rate of postnatal ultrasound
Rate of postnatal ultrasound
Measured: day 1
type of intestinal malrotation
type of intestinal malrotation
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jan 2020
- Primary completion1 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal ComplicationStudies 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent FUCHS, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148429
- Sponsor's protocol ID
- RECHMPL21_0684
- Acronym
- MALROT
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2021
- Last updated
- 23 Dec 2021
- 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 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of the Ultrasound Study of the Relative Position of the Superior Mesenteric Vessels and Fetal Abdominal MRI.
- ClinicalTrials.gov ID
- NCT05148429
- Acronym / sponsor ID
- MALROT / RECHMPL21_0684
- Conditions
- Postnatal Complication, Mesenteric Pregnancy
- Keywords
- Pregnant women, 2nd trimester ultrasound examination, Mesenteric vessels positionning, Pediatric follow up +/- treatment, Postnatal confirmation, Evolution and complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 Dec 2021 (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.
Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.
The aim of the study is to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetuses with abnormal positionning of mesenteric vessels | – | Other: Ultrasound exam, Other: Fetal MRI, Other: Postnatal abdominal ultrasound, Other: Pediatric Follow upAll pregnant women with abnormal positionning of mesenteric vessels during second trimester scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women attending for 2nd trimester scan
Key inclusion criteria (5 listed)
- Pregnant women attending for 2nd trimester ultrasound
- Abnormal positionning of mesenteric vessels
- No other foetal malformation
- Singleton pregnancy
- Age >18 years
Key exclusion criteria (3 listed)
- Chromosomal abnormality
- polymalformative syndrom
- Foetal malformation changing intestine disposition (gastroschisis, diaphragmatic hernia, heterotaxis…)
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 |
|---|---|---|
| Ultrasound examUltrasound exam | Other | Fetuses with abnormal positionning of mesenteric vessels |
| Fetal MRIFetal MRI | Other | Fetuses with abnormal positionning of mesenteric vessels |
| Postnatal abdominal ultrasoundPostnatal abdominal ultrasound | Other | Fetuses with abnormal positionning of mesenteric vessels |
| Pediatric Follow upPediatric Follow up | Other | Fetuses with abnormal positionning of mesenteric vessels |
Primary outcome
Percentage of intestinal malrotation among foetuses
Time frame: day 1
Percentage of intestinal malrotation among foetuses with abnormal positionning of mesenteric vessels
3 secondary outcomes
Rate of correlation between prenatal
Time frame: day 1
Rate of postnatal ultrasound
Time frame: day 1
type of intestinal malrotation
Time frame: day 1
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 23 Dec 2021.
- Individual participant dataSharing planned: Undecided. NC
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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, PhD 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 Postnatal Complication and Mesenteric Pregnancy, 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 5 inclusion and 3 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 23 Dec 2021. 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?
Percentage of intestinal malrotation among foetuses (time frame: day 1). 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 23 Dec 2021.