Singleton-Merten SyndromeSMANCT05204771
Prenatal US Assessment of Superior Mesenteric Vessels for Digestive Rotation
An observational study of Singleton-Merten Syndrome and Postnatal Complication, 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
- Singleton-Merten Syndrome, Postnatal Complication
- What is being tested?
- Ultrasound exam, Postnatal abdominal ultrasound and Pediatric Follow up
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 1 Oct 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 3rd timester scan
Who may be able to join
- Pregnant women attending for 3rd trimester ukltrasound
- Uneventfull pregnancy
- No foetal malformation
- Singleton pregnancy
- Age >18 years
Who cannot join
- Other condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prenatal Ultrasound Assessment of the Relative Position of the Superior Mesenteric Artery and Vein to Define the Status of Digestive Rotation: a Prenatal Tool of Intestinal Malrotation Diagnosis?
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 ti evaluate the ability to identiy prenataly during ultrasound examination, the relative positionning of the fetal mesenteric vessels, and then to correlate it with the real postnatal positionning (gold standard)
Read the detailed description
- Prenatal US assessment of mesenteric vessels positioning (relative position of the vein vs artery) during routine 3rd trimester US scan
- Description of various anatomical situation
- Comparison of this prenatal positioning with postnatal positioning obtained through abdominal ultrasound examination. Post-natal ultrasound being the gold standard
- Conditions
- Singleton-Merten Syndrome, Postnatal Complication
- Being tested
- Ultrasound exam, Postnatal abdominal ultrasound, Pediatric Follow up
- Keywords
- Evolution and complication, Mesenteric vessels positionning, 3rd ultrasound examination, Pediatric follow up +/- treatment
- Medical subject headings
- Singleton Merten syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examOther
Ultrasound exam
Postnatal abdominal ultrasoundOther
Postnatal abdominal ultrasound
Pediatric Follow upOther
Pediatric Follow up
| Study group | Role | What they receive |
|---|---|---|
| Normal foetus | All pregnant women reffered for 3rd trimester routine ultrasound examination without any fetal abnormality Receives: Other: Ultrasound exam; 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.
Prenatal ultrasound evaluation
Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric vein in comparison to the superior mesenteric artery
Measured: day 1
Secondary outcomes (2)
Prenatal ultrasound evaluation
Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric artery in comparison to the superior mesenteric vein
Measured: day 1
Prenatal ultrasound evaluation
Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric artery in comparison to the superior mesenteric aorta
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 posted24 Jan 2022
- Study start1 Jun 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Singleton-Merten SyndromeStudies 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
- 80 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
- NCT05204771
- Sponsor's protocol ID
- RECHMPL21_0683
- Acronym
- SMA
- Status last verified
- Jan 2022
- First submitted
- 24 Nov 2021
- Last updated
- 24 Jan 2022
- 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 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Ultrasound Assessment of the Relative Position of the Superior Mesenteric Artery and Vein to Define the Status of Digestive Rotation: a Prenatal Tool of Intestinal Malrotation Diagnosis?
- ClinicalTrials.gov ID
- NCT05204771
- Acronym / sponsor ID
- SMA / RECHMPL21_0683
- Conditions
- Singleton-Merten Syndrome, Postnatal Complication
- Keywords
- Evolution and complication, Mesenteric vessels positionning, 3rd ultrasound examination, Pediatric follow up +/- treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 24 Jan 2022 (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 ti evaluate the ability to identiy prenataly during ultrasound examination, the relative positionning of the fetal mesenteric vessels, and then to correlate it with the real postnatal positionning (gold standard)
Detailed description
- Prenatal US assessment of mesenteric vessels positioning (relative position of the vein vs artery) during routine 3rd trimester US scan
- Description of various anatomical situation
- Comparison of this prenatal positioning with postnatal positioning obtained through abdominal ultrasound examination. Post-natal ultrasound being the gold standard
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal foetus | – | Other: Ultrasound exam, Other: Postnatal abdominal ultrasound, Other: Pediatric Follow upAll pregnant women reffered for 3rd trimester routine ultrasound examination without any fetal abnormality |
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 3rd timester scan
Key inclusion criteria (5 listed)
- Pregnant women attending for 3rd trimester ukltrasound
- Uneventfull pregnancy
- No foetal malformation
- Singleton pregnancy
- Age >18 years
Key exclusion criteria (1 listed)
- Other condition
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 | Normal foetus |
| Postnatal abdominal ultrasoundPostnatal abdominal ultrasound | Other | Normal foetus |
| Pediatric Follow upPediatric Follow up | Other | Normal foetus |
Primary outcome
Prenatal ultrasound evaluation
Time frame: day 1
Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric vein in comparison to the superior mesenteric artery
2 secondary outcomes
Prenatal ultrasound evaluation
Time frame: day 1
Prenatal ultrasound evaluation
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 24 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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 Singleton-Merten Syndrome and Postnatal Complication, 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 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 Jan 2022. 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?
Prenatal ultrasound evaluation (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 24 Jan 2022.