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NCT04729361 Clinical Trial

CGH-array in Prenatal Diagnosis of Isolated Severe and Early Intra-uterine Growth Restriction

Genetic Disease Clinical Trial

Official title:
CGH-array in Prenatal Diagnosis of Isolated Severe and Early Intra-uterine Growth Restriction

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04729361
Other study ID # 2021PI007
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 31, 2021
Est. completion date November 30, 2021

Study information
Verified date January 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

According to french recommandations for IUGR management we have to propose a CGH-array analysis if the IUGR is severe (bellow the 3rd percentile) and early (in the second trimester). However there is no data to support this point of view.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date November 30, 2021
Est. primary completion date March 15, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - pregnant women - fetus with an isolated intra-uterine growth restriction (IUGR) severe (bellow the third percentile on CFEF curves) and early (between 21 and 24 gestational weeks). Exclusion Criteria: - associated IUGR (with other abnormalities during prenatal screening)

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• CGH array analysis
CGH array analysis

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary rate of abnormal CGH-array in the groupe "severe and early" UGR one-time (at the time of the analysis)
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