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NCT03582111 Clinical Trial

Ultrasound Diagnosis of Cleft Lip and Palate

Cleft Lip and Palate Clinical Trial

— FENCHU  

Official title:
Ultrasound Diagnosis of Cleft Lip and Palate - FENCHU

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03582111
Other study ID # RECHMPL18_0284
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2009
Est. completion date May 2018

Study information
Verified date June 2018
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present.

The aim of this study is to continue this study from 2009 till 2016. The hypothesis is that the diagnosis rate is constant since 2005.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date May 2018
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 46 Years
Eligibility Inclusion criteria:

- Age over 18

- Prenatal ultrasound diagnosis of cleft palate/lip.

- Viable pregnancy or Intrauterine fetal demise or medical termination of pregnancy

Exclusion criteria:

- Diagnosis not confirmed at birth and ultrasound picture not interpretable

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Study of medical records
Study of medical records

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 Compare the prenatal and postnatal diagnosis of cleft lip and palate Compare the prenatal and postnatal diagnosis of cleft lip and palate At birth
Secondary Study the cleft palate diagnosis when cleft lip is present Study the cleft palate diagnosis when cleft lip is present At birth
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