Fetal VolvulusNCT03362450
Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features
An observational study of Fetal Volvulus and Midgut Volvulus, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Volvulus, Midgut Volvulus
- What is being tested?
- Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examination
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2006to 30 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pregnant women
Who may be able to join
- postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings
Who cannot join
- the absence of prenatal imaging assessment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fetal Volvulus, Midgut Volvulus
- Being tested
- Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examination
- Keywords
- 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
- Medical subject headings
- Volvulus Of Midgut
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examinationOther
Fetal ultrasound during the second or third trimester Postnatal surgery Post mortem examination
| Study group | Role | What they receive |
|---|---|---|
| Pregnant patients seen for second or third trimester | Foetus with diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings Receives: Other: Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the second (22-24 weeks) after ultrasound screening
echography
Observation of specific signs using echography for the diagnosis of fetal
Measured: the third (31-34 weeks) trimester after ultrasound screening
Secondary outcomes (12)
ultrasound signs of complication
Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.
Measured: the third (31-34 weeks) after ultrasound screening
ultrasound signs of complication
Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.
Measured: during the second (22-24 weeks) after ultrasound screening
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.
Measured: 1 day
ultrasound signs of complication
Observation of ultrasound signs of complication of midgut volvulus during the pregnancy like meconial pseudocyst, ascites, meconial peritonitis.
Measured: just after delivery
presence or not of the volvulus
Observation of surgery outcome like presence or not of the volvulus after diagnostic ultrasound
Measured: 1 day
presence or not of the volvulus
Observation of surgery outcome like presence or not of the volvulus
Measured: during the second (22-24 weeks) after ultrasound screening
presence or not of the volvulus
Observation of surgery outcome like presence or not of the volvulus
Measured: just after delivery
presence or not of the volvulus
Observation of surgery outcome like presence or not of the volvulus
Measured: the third (31-34 weeks) after ultrasound screening
presence or not ileal atresia.
Observation of surgery outcome like presence or not ileal atresia
Measured: during the second (22-24 weeks) after ultrasound screening
presence or not ileal atresia.
Observation of surgery outcome like presence or not ileal atresia
Measured: the third (31-34 weeks) after ultrasound screening
presence or not ileal atresia.
Observation of surgery outcome like presence or not ileal atresia
Measured: just after delivery
presence or not ileal atresia.
Observation of surgery outcome like presence or not ileal atresia after diagnostic ultrasound
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Jan 2006
- Primary completion1 Jul 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal VolvulusStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362450
- Sponsor's protocol ID
- RECHMPL17_0321
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features
- ClinicalTrials.gov ID
- NCT03362450
- Acronym / sponsor ID
- RECHMPL17_0321
- Conditions
- Fetal Volvulus, Midgut Volvulus
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 5 Dec 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.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant patients seen for second or third trimester | – | Other: Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examinationFoetus with diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women
Key inclusion criteria (1 listed)
- postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings
Key exclusion criteria (1 listed)
- the absence of prenatal imaging assessment
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 |
|---|---|---|
| Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examinationFetal ultrasound during the second or third trimester Postnatal surgery Post mortem examination | Other | Pregnant patients seen for second or third trimester |
Primary outcome
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
echography
Time frame: the third (31-34 weeks) trimester after ultrasound screening
Observation of specific signs using echography for the diagnosis of fetal
12 secondary outcomes
ultrasound signs of complication
Time frame: the third (31-34 weeks) after ultrasound screening
ultrasound signs of complication
Time frame: during the second (22-24 weeks) after ultrasound screening
ultrasound signs of complication
Time frame: 1 day
ultrasound signs of complication
Time frame: just after delivery
presence or not of the volvulus
Time frame: 1 day
presence or not of the volvulus
Time frame: during the second (22-24 weeks) after ultrasound screening
presence or not of the volvulus
Time frame: just after delivery
presence or not of the volvulus
Time frame: the third (31-34 weeks) after ultrasound screening
presence or not ileal atresia.
Time frame: during the second (22-24 weeks) after ultrasound screening
presence or not ileal atresia.
Time frame: the third (31-34 weeks) after ultrasound screening
presence or not ileal atresia.
Time frame: just after delivery
presence or not ileal atresia.
Time frame: 1 day
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 5 Dec 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fetal Volvulus and Midgut Volvulus, 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 1 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 5 Dec 2017. 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?
echography (time frame: during the second (22-24 weeks) after ultrasound screening). The study lists 2 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 5 Dec 2017.