NCT04541966|Completed
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Sponsor study identifier
observational
230
1 country
1
Study Start
May 1, 2020
Actual (reported)Primary Completion
May 1, 2020
Actual (reported)Study Completion
September 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2020
Actual (reported)May 1, 2020
Actual (reported)September 1, 2020
Actual (reported)September 1, 2020
Actual (reported)September 9, 2020
Actual (reported)Pregnancies without ultrasound or genetic abnormalities
Pregnancies without ultrasound or genetic abnormalities
immediate antenatal and postnatal period
ACPA interest
immediate antenatal and postnatal period
percentage of samples for high risk combined for trisomy 21
immediate antenatal and postnatal period
Pregnancy outcomes
immediate antenatal and postnatal period
Nuchal translucency\> = 99th percentile and \<3.5mm
Nuchal translucency\> = 3.5 mm
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.
Uhmontpellier
Montpellier, 34295, France
Florent FUCHS, PhD
University Hospital, Montpellier
230 participants (actual enrollment reported by the registry).
First Submitted
September 1, 2020
First Posted
September 9, 2020
Study Start
May 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 1, 2020
Actual (reported)Study Completion
September 1, 2020
Actual (reported)Last Updated
September 10, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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