Nuchal TranslucencyNCT04541966
What Happens to First Trimester Nuchal Translucency
An observational study of Nuchal Translucency, run by University Hospital, Montpellier at 1 site in France.
Trial summary
First trimester nuchal translucency is a call point for genetic abnormalities and birth defects. Nuchal translucency varies with LCC and therefore with gestational age as described by Chung et al who created a 99th percentile curve of nuchal translucency versus LCC. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Nuchal Translucency
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 1 Sep 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Single pregnancies with nuchal hyperclarity in the first trimester> = 99th percentile at the Montpellier University Hospital with early pregnancy between January 2017 and December 2019.
Who may be able to join
- nuchal translucency> = 99th percentile
Who cannot join
- multiple pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Happens to First Trimester Nuchal Translucency Greater Than or Equal 99ème Percentile and Inferior 3.5 mm
First trimester nuchal translucency is a call point for genetic abnormalities and birth defects. Nuchal translucency varies with LCC and therefore with gestational age as described by Chung et al who created a 99th percentile curve of nuchal translucency versus LCC. The majority of centers use the 3.5 mm cutoff as the 99th percentile instead of using nuchal translucency based on LCC. The objective of this study is to compare the fate of nuchal hyperclites> = 99th p but <3.5mm versus 3.5mm. For this the investigators have studied the ultrasound and genetic abnormalities. The investigators were also interested in the pregnancy outcomes and the percentage of pregnancies in the group> = 99th p and <3.5mm that would have been sampled for a high combined risk for trisomy 21, and therefore to determine the benefit of a systematic sample. for HCN as well as the interest of performing an ACPA that would not be performed on a sample with a high risk of trisomy 21.
- Conditions
- Nuchal Translucency
- Keywords
- Ultrasound abnormalities, Genetic abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nuchal translucency> = 99th percentile and <3.5mm | Nuchal translucency> = 99th percentile and <3.5mm | |
| Nuchal translucency> = 3.5 mm | Nuchal translucency> = 3.5 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancies without ultrasound or genetic abnormalities
Pregnancies without ultrasound or genetic abnormalities
Measured: immediate antenatal and postnatal period
Secondary outcomes (3)
ACPA interest
ACPA interest
Measured: immediate antenatal and postnatal period
percentage of samples for high risk combined for trisomy 21
percentage of samples for high risk combined for trisomy 21
Measured: immediate antenatal and postnatal period
Pregnancy outcomes
Pregnancy outcomes
Measured: immediate antenatal and postnatal period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 May 2020
- Primary completion1 May 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nuchal TranslucencyStudies 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
- 230 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
- NCT04541966
- Sponsor's protocol ID
- RECHMPL20_0479
- Status last verified
- Jun 2020
- First submitted
- 1 Sep 2020
- Last updated
- 10 Sep 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 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Happens to First Trimester Nuchal Translucency Greater Than or Equal 99ème Percentile and Inferior 3.5 mm
- ClinicalTrials.gov ID
- NCT04541966
- Acronym / sponsor ID
- RECHMPL20_0479
- Conditions
- Nuchal Translucency
- Keywords
- Ultrasound abnormalities, Genetic abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 9 Sep 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.
First trimester nuchal translucency is a call point for genetic abnormalities and birth defects. Nuchal translucency varies with LCC and therefore with gestational age as described by Chung et al who created a 99th percentile curve of nuchal translucency versus LCC. The majority of centers use the 3.5 mm cutoff as the 99th percentile instead of using nuchal translucency based on LCC. The objective of this study is to compare the fate of nuchal hyperclites> = 99th p but <3.5mm versus 3.5mm. For this the investigators have studied the ultrasound and genetic abnormalities. The investigators were also interested in the pregnancy outcomes and the percentage of pregnancies in the group> = 99th p and <3.5mm that would have been sampled for a high combined risk for trisomy 21, and therefore to determine the benefit of a systematic sample. for HCN as well as the interest of performing an ACPA that would not be performed on a sample with a high risk of trisomy 21.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nuchal translucency> = 99th percentile and <3.5mm | – | –Nuchal translucency> = 99th percentile and <3.5mm |
| Nuchal translucency> = 3.5 mm | – | –Nuchal translucency> = 3.5 mm |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Single pregnancies with nuchal hyperclarity in the first trimester> = 99th percentile at the Montpellier University Hospital with early pregnancy between January 2017 and December 2019.
Key inclusion criteria (1 listed)
- nuchal translucency> = 99th percentile
Key exclusion criteria (1 listed)
- multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancies without ultrasound or genetic abnormalities
Time frame: immediate antenatal and postnatal period
Pregnancies without ultrasound or genetic abnormalities
3 secondary outcomes
ACPA interest
Time frame: immediate antenatal and postnatal period
percentage of samples for high risk combined for trisomy 21
Time frame: immediate antenatal and postnatal period
Pregnancy outcomes
Time frame: immediate antenatal and postnatal period
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 10 Sep 2020.
- 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 Nuchal Translucency, 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 10 Sep 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?
Pregnancies without ultrasound or genetic abnormalities (time frame: immediate antenatal and postnatal period). 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 10 Sep 2020.