Cleft Lip and PalateFENCHUNCT03582111
Ultrasound Diagnosis of Cleft Lip and Palate
An observational study of Cleft Lip and Palate, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present. The aim of this study is to continue this study from 2009 till 2016. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Study of medical records
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to May 2018
- 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 to 46 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Fœtus with cleft lip diagnosed at mid-trimester ultrasound screening in Montpellier hospital (Arnaud de Villeneuve) between February 2009 and December 2016.
Who may be able to join
- Age over 18
- Prenatal ultrasound diagnosis of cleft palate/lip.
- Viable pregnancy or Intrauterine fetal demise or medical termination of pregnancy
Who cannot join
- Diagnosis not confirmed at birth and ultrasound picture not interpretable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Diagnosis of Cleft Lip and Palate - FENCHU
Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present.
The aim of this study is to continue this study from 2009 till 2016. The hypothesis is that the diagnosis rate is constant since 2005.
- Conditions
- Cleft Lip and Palate
- Being tested
- Study of medical records
- Keywords
- Ultrasound, Pregnancy, Diagnosis
- Medical subject headings
- Cleft Lip, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of medical recordsOther
Study of medical records
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women who have a foetus with a cleft lip/palate | Pregnant women who have a foetus with a cleft lip/palate Receives: Other: Study of medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the prenatal and postnatal diagnosis of cleft lip and palate
Compare the prenatal and postnatal diagnosis of cleft lip and palate
Measured: At birth
Secondary outcomes (1)
Study the cleft palate diagnosis when cleft lip is present
Study the cleft palate diagnosis when cleft lip is present
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study startFeb 2009
- Primary completionDec 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrielle LEFEBVRE, Midwife, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582111
- Sponsor's protocol ID
- RECHMPL18_0284
- Acronym
- FENCHU
- Status last verified
- Jun 2018
- First submitted
- 27 Jun 2018
- Last updated
- 11 Jul 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 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Diagnosis of Cleft Lip and Palate - FENCHU
- ClinicalTrials.gov ID
- NCT03582111
- Acronym / sponsor ID
- FENCHU / RECHMPL18_0284
- Conditions
- Cleft Lip and Palate
- Keywords
- Ultrasound, Pregnancy, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 10 Jul 2018 (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.
Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present.
The aim of this study is to continue this study from 2009 till 2016. The hypothesis is that the diagnosis rate is constant since 2005.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women who have a foetus with a cleft lip/palate | – | Other: Study of medical recordsPregnant women who have a foetus with a cleft lip/palate |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Fœtus with cleft lip diagnosed at mid-trimester ultrasound screening in Montpellier hospital (Arnaud de Villeneuve) between February 2009 and December 2016.
Key inclusion criteria (3 listed)
- Age over 18
- Prenatal ultrasound diagnosis of cleft palate/lip.
- Viable pregnancy or Intrauterine fetal demise or medical termination of pregnancy
Key exclusion criteria (1 listed)
- Diagnosis not confirmed at birth and ultrasound picture not interpretable
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 |
|---|---|---|
| Study of medical recordsStudy of medical records | Other | Pregnant women who have a foetus with a cleft lip/palate |
Primary outcome
Compare the prenatal and postnatal diagnosis of cleft lip and palate
Time frame: At birth
Compare the prenatal and postnatal diagnosis of cleft lip and palate
1 secondary outcome
Study the cleft palate diagnosis when cleft lip is present
Time frame: At birth
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 11 Jul 2018.
- 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.
Cyrielle LEFEBVRE, Midwife 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 Cleft Lip and Palate, 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 3 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 11 Jul 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?
Compare the prenatal and postnatal diagnosis of cleft lip and palate (time frame: At birth). 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 11 Jul 2018.