Ultrasound Fetal MedicineHYPERCLAIRNCT04028453
Follow up of Increased Nuchal Translucency :Study of 2010 to 2018 of Limoges Hospital
An observational study of Ultrasound Fetal Medicine, run by University Hospital, Limoges at 1 site in France.
Trial summary
The ultrasound of the first trimester allows to determinate the pregnancy beginning, the type of pregnancy and also to detect increased nuchal translucency (NT). Fetuses with common chromosomal abnormalities (trisomies 21, 18 and 13 and monosomy X) and structural abnormalities (particularly cardiac defects) and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ultrasound Fetal Medicine
- What is being tested?
- Survey
- How many people
- 392 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2019to 25 Oct 2020
- 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
- Adult, Older adult
Study population: Patient with nuchal translucency of the fetus> 95th percentile in the first trimester of pregnancy
Who may be able to join
- Increased nucal translucency (NT) > 95e percentile on the pregnancy's first trimester
- Monofoetal pregnancy
- Twin pregnancy (biamniotic bichorial)
- Adult patients
Who cannot join
- Increased NT < 95e percentile on the pregnancy's first trimester
- Increased NT > 95e percentile on the pregnancy's second trimester
- Twin pregnancy (biamniotic monochorial), triple or more gestation
- Underage patients
Trial locations and contacts
1 site in 1 country.
About this study
The ultrasound of the first trimester allows to determinate the pregnancy beginning, the type of pregnancy and also to detect increased nuchal translucency (NT). Fetuses with common chromosomal abnormalities (trisomies 21, 18 and 13 and monosomy X) and structural abnormalities (particularly cardiac defects) and single-gene disorders frequently show increased NT. The purpose of this study is to evaluate in the population of Limousin, the type and frequency of these abnormalities.
Read the detailed description
Increased NT superior than 95th percentile (Nicolaides curves) during the ultrasound of the first trimester, are associated to common chromosomal abnormalities. It's therefore necessary to make amniocentesis and to analyze karyotyping and Genomic microarrays, also known as chromosomal microarrays (CMA). In euploid foetus, increased NT is also associated with structural defects or genetic syndromes. Additionally, the overall long-term growth of euploid children with increased NT is not much known. The majority (98%) of euploid children with a normal second trimester ultrasound is apparently healthy in the short run. The investigator's objective is to evaluate in a retrospective way, different events (structural defects, chromosomal or genetic abnormalities) during these pregnancies. In a prospective way, the neurodevelopmental disorders in euploid children will be investigated.
- Conditions
- Ultrasound Fetal Medicine
- Being tested
- Survey
- Keywords
- Increased nuchal translucency, prenatal diagnosis, karyotype analysis, chromosome micro-array analysis, neurodevelopmental disorders, euploid children
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
There will be a first part with a retrospective study in order to collect pregnancy data to answer to the primary endpoint. Then, there will be a prospective part where mothers and their children will have to answer an evaluation survey.
| Study group | Role | What they receive |
|---|---|---|
| Mother | There will be a first part with a retrospective study in order to collect pregnancy data to answer to the primary endpoint. Then, there will be a prospective part where mothers and their children will have to answer an evaluation questionnaire. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of chromosomal abnormalities on fetuses with increased nuchal translucency
Characterization of fetuses with increased nuchal translucency by Identification of chromosomal abnormalities, structural defects and genetic syndromes on fetuses with increased nuchal translucency
Measured: 6 months
Number structural defects on fetuses with increased nuchal translucency
Characterization of fetuses with increased nuchal translucency by Identification of chromosomal abnormalities, structural defects and genetic syndromes on fetuses with increased nuchal translucency
Measured: 6 months
Number of genetic syndromes on fetuses with increased nuchal translucency
Characterization of fetuses with increased nuchal translucency by Identification of chromosomal abnormalities, structural defects and genetic syndromes on fetuses with increased nuchal translucency
Measured: 6 months
Secondary outcomes (9)
Rate of each Pregnancy outcomes
Numbers of alive children, fetal death in utero, abortions on medical grounds, stillborn, children born prematurely
Measured: 1 year
structural defects
Numbers and type term of structural defects
Measured: 1 year
maternofetal infection
number and type of maternofetal infection
Measured: 1 year
postnatal structural defects
Numbers and type of postnatal structural defects
Measured: 1 year
postnatal chromosomal abnormalities
Number and type of postnatal chromosomal abnormalities
Measured: 1 year
postnatal genetic syndromes
Number and type of postnatal genetic syndromes
Measured: 1 year
Determination of a neck thickness threshold at risk of psychomotor developmental delay
Neurodevelopmental evaluation score of Age Stage Questionnaire ASQ-3 (for 2 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years children) or Global School Adaptation GSA (from 6 to 8 years children).
Measured: 1 year
Determination of a neck thickness threshold at risk of malformations and requiring the persistence of monthly ultrasound monitoring
Numbers and type of postnatal structural defects
Measured: 1 year
Study of the psychomotor development of nuchal translucency with normal genetic analysis
Neurodevelopmental evaluation score of Age Stage Questionnaire (ASQ-3) (for 2 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years children without genetic abnormalities) or Global School Adaptation (GSA) (from 6 to 8 years children without genetic abnormalities).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start25 Oct 2019
- Primary completion25 Oct 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Fetal MedicineStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Other
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028453
- Sponsor's protocol ID
- 87RI19_0030 (HYPERCLAIR)
- Acronym
- HYPERCLAIR
- Status last verified
- Sep 2021
- First submitted
- 15 Jul 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Increased Nuchal Translucency :Study of 2010 to 2018 of Limoges Hospital
- ClinicalTrials.gov ID
- NCT04028453
- Acronym / sponsor ID
- HYPERCLAIR / 87RI19_0030 (HYPERCLAIR)
- Conditions
- Ultrasound Fetal Medicine
- Keywords
- Increased nuchal translucency, prenatal diagnosis, karyotype analysis, chromosome micro-array analysis, neurodevelopmental disorders, euploid children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 22 Jul 2019 (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.
The ultrasound of the first trimester allows to determinate the pregnancy beginning, the type of pregnancy and also to detect increased nuchal translucency (NT). Fetuses with common chromosomal abnormalities (trisomies 21, 18 and 13 and monosomy X) and structural abnormalities (particularly cardiac defects) and single-gene disorders frequently show increased NT. The purpose of this study is to evaluate in the population of Limousin, the type and frequency of these abnormalities.
Detailed description
Increased NT superior than 95th percentile (Nicolaides curves) during the ultrasound of the first trimester, are associated to common chromosomal abnormalities. It's therefore necessary to make amniocentesis and to analyze karyotyping and Genomic microarrays, also known as chromosomal microarrays (CMA). In euploid foetus, increased NT is also associated with structural defects or genetic syndromes. Additionally, the overall long-term growth of euploid children with increased NT is not much known. The majority (98%) of euploid children with a normal second trimester ultrasound is apparently healthy in the short run. The investigator's objective is to evaluate in a retrospective way, different events (structural defects, chromosomal or genetic abnormalities) during these pregnancies. In a prospective way, the neurodevelopmental disorders in euploid children will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother | – | Other: SurveyThere will be a first part with a retrospective study in order to collect pregnancy data to answer to the primary endpoint. Then, there will be a prospective part where mothers and their children will have to answer an evaluation questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patient with nuchal translucency of the fetus> 95th percentile in the first trimester of pregnancy
Key inclusion criteria (4 listed)
- Increased nucal translucency (NT) > 95e percentile on the pregnancy's first trimester
- Monofoetal pregnancy
- Twin pregnancy (biamniotic bichorial)
- Adult patients
Key exclusion criteria (4 listed)
- Increased NT < 95e percentile on the pregnancy's first trimester
- Increased NT > 95e percentile on the pregnancy's second trimester
- Twin pregnancy (biamniotic monochorial), triple or more gestation
- Underage patients
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 |
|---|---|---|
| SurveyThere will be a first part with a retrospective study in order to collect pregnancy data to answer to the primary endpoint. Then, there will be a prospective part where mothers and their children will have to answer an evaluation survey. | Other | Mother |
Primary outcome
Number of chromosomal abnormalities on fetuses with increased nuchal translucency
Time frame: 6 months
Characterization of fetuses with increased nuchal translucency by Identification of chromosomal abnormalities, structural defects and genetic syndromes on fetuses with increased nuchal translucency
Number structural defects on fetuses with increased nuchal translucency
Time frame: 6 months
Characterization of fetuses with increased nuchal translucency by Identification of chromosomal abnormalities, structural defects and genetic syndromes on fetuses with increased nuchal translucency
Number of genetic syndromes on fetuses with increased nuchal translucency
Time frame: 6 months
Characterization of fetuses with increased nuchal translucency by Identification of chromosomal abnormalities, structural defects and genetic syndromes on fetuses with increased nuchal translucency
9 secondary outcomes
Rate of each Pregnancy outcomes
Time frame: 1 year
structural defects
Time frame: 1 year
maternofetal infection
Time frame: 1 year
postnatal structural defects
Time frame: 1 year
postnatal chromosomal abnormalities
Time frame: 1 year
postnatal genetic syndromes
Time frame: 1 year
Determination of a neck thickness threshold at risk of psychomotor developmental delay
Time frame: 1 year
Determination of a neck thickness threshold at risk of malformations and requiring the persistence of monthly ultrasound monitoring
Time frame: 1 year
Study of the psychomotor development of nuchal translucency with normal genetic analysis
Time frame: 1 year
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 8 Sep 2021.
- Individual participant dataSharing planned: No
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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.
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 Ultrasound Fetal Medicine, run by University Hospital, Limoges 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 4 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 8 Sep 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?
Number of chromosomal abnormalities on fetuses with increased nuchal translucency (time frame: 6 months). The study lists 3 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 8 Sep 2021.