What Happens to First Trimester Nuchal Translucency

Nuchal Translucency Clinical Trial

Official title:

What Happens to First Trimester Nuchal Translucency Greater Than or Equal 99ème Percentile and Inferior 3.5 mm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541966
• Other study ID #: RECHMPL20_0479
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: September 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion criteria:

nuchal translucency> = 99th percentile

Exclusion criteria:

• multiple pregnancies

Related Conditions & MeSH terms

• Nuchal Translucency

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancies without ultrasound or genetic abnormalities	Pregnancies without ultrasound or genetic abnormalities	immediate antenatal and postnatal period
Secondary	ACPA interest	ACPA interest	immediate antenatal and postnatal period
Secondary	percentage of samples for high risk combined for trisomy 21	percentage of samples for high risk combined for trisomy 21	immediate antenatal and postnatal period
Secondary	Pregnancy outcomes	Pregnancy outcomes	immediate antenatal and postnatal period