What Happens to First Trimester Nuchal Translucency

Completed

• Conditions: Nuchal Translucency

• Registration Number: NCT04541966
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2020-05-01
• Status Verified: 2020-06
• Study Completion: 2020-09-01
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-08
• Study First Posted: 2020-09-09
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancies without ultrasound or genetic abnormalities	immediate antenatal and postnatal period	Pregnancies without ultrasound or genetic abnormalities

Secondary Outcome Measures

Name	Time	Method
ACPA interest	immediate antenatal and postnatal period	ACPA interest
percentage of samples for high risk combined for trisomy 21	immediate antenatal and postnatal period	percentage of samples for high risk combined for trisomy 21
Pregnancy outcomes	immediate antenatal and postnatal period	Pregnancy outcomes

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France