Pierre Robin SequenceNCT04422067
Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia
An observational study of Pierre Robin Sequence, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be present at birth. After birth, the diagnosis of retrognathia is based on the clinical examination. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Pierre Robin Sequence
- What is being tested?
- Fetal cephalometry
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 30 Sep 2019
- 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 44 years
- All sexes
- No healthy volunteers
- Adult
Study population: All pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence
Who may be able to join
- Pregnant patient (Aged >18years old)
- with one or more fetuses suffering from a microretrognathia
- diagnosed prenatally
- integrated into a Pierre Robin Sequence
Who cannot join
- Uncvertain diagnosis
- Absence of 3D rendering volume
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia : Prenatal Cephal
Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be present at birth. After birth, the diagnosis of retrognathia is based on the clinical examination. Cephalometry can be used to complete the diagnosis. Several authors have proposed the use of objective quantitative ultrasound parameters for the antenatal screening of PRS. In our study, the investigators evaluated fetal cephalometry.
The aim First, the investigators studied the inter- and intra-observer reproducibility of cephalometry. Second, the investigators established reference values for antenatal cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance of cephalometry and the other angles described in the literature for the diagnosis of retrognathia.
- Conditions
- Pierre Robin Sequence
- Being tested
- Fetal cephalometry
- Keywords
- with one or more fetuses suffering from a microretrognathia, Cephalometry, Prenatal Diagnosis, Facial angles, Fetal echography, Microretrognathia, diagnosed prenatally
- Medical subject headings
- Pierre Robin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal cephalometryOther
Fetal cephalometry
| Study group | Role | What they receive |
|---|---|---|
| Case group (Retrognatism) | All pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence, were included. All cases were confirmed postnatally, either by a pediatric examination or by a fetopathological examination in the case of a medical termination of the pregnancy. We had 21 cases. Receives: Other: Fetal cephalometry | |
| Control group | 47 pregnant patients with fetus without facial abnormalities Receives: Other: Fetal cephalometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of cephalometry
Reproducibility of cephalometry
Measured: During ultrasound
Secondary outcomes (1)
Perfomance of several angle to diagnose retrognatism
Perfomance of several angle to diagnose retrognatism
Measured: During ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 May 2019
- Primary completion1 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pierre Robin SequenceStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 68 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
- NCT04422067
- Sponsor's protocol ID
- RECHMPL20_0295
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 11 Jun 2020
- 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 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia : Prenatal Cephal
- ClinicalTrials.gov ID
- NCT04422067
- Acronym / sponsor ID
- RECHMPL20_0295
- Conditions
- Pierre Robin Sequence
- Keywords
- with one or more fetuses suffering from a microretrognathia, Cephalometry, Prenatal Diagnosis, Facial angles, Fetal echography, Microretrognathia, diagnosed prenatally
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 9 Jun 2020 (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.
Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be present at birth. After birth, the diagnosis of retrognathia is based on the clinical examination. Cephalometry can be used to complete the diagnosis. Several authors have proposed the use of objective quantitative ultrasound parameters for the antenatal screening of PRS. In our study, the investigators evaluated fetal cephalometry.
The aim First, the investigators studied the inter- and intra-observer reproducibility of cephalometry. Second, the investigators established reference values for antenatal cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance of cephalometry and the other angles described in the literature for the diagnosis of retrognathia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group (Retrognatism) | – | Other: Fetal cephalometryAll pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence, were included. All cases were confirmed postnatally, either by a pediatric examination or by a fetopathological examination in the case of a medical termination of the pregnancy. We had 21 cases. |
| Control group | – | Other: Fetal cephalometry47 pregnant patients with fetus without facial abnormalities |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence
Key inclusion criteria (4 listed)
- Pregnant patient (Aged >18years old)
- with one or more fetuses suffering from a microretrognathia
- diagnosed prenatally
- integrated into a Pierre Robin Sequence
Key exclusion criteria (2 listed)
- Uncvertain diagnosis
- Absence of 3D rendering volume
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 cephalometryFetal cephalometry | Other | Case group (Retrognatism), Control group |
Primary outcome
Reproducibility of cephalometry
Time frame: During ultrasound
Reproducibility of cephalometry
1 secondary outcome
Perfomance of several angle to diagnose retrognatism
Time frame: During ultrasound
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 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Pierre Robin Sequence
Active, not recruitingObservational study
3D-CT-Based Prediction of Difficult Laryngoscopy in Infants With Pierre Robin Sequence
Pierre Robin Sequence (PRS), Difficult Laryngoscopy
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 Pierre Robin Sequence, 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 4 inclusion and 2 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 Jun 2020. 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 cephalometry (time frame: During ultrasound). 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 Jun 2020.