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Ultrasound Diagnosis of Cleft Lip and Palate (FENCHU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03582111
Recruitment Status : Completed
First Posted : July 10, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.


Condition or disease Intervention/treatment
Cleft Lip and Palate Other: Study of medical records

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Ultrasound Diagnosis of Cleft Lip and Palate - FENCHU
Actual Study Start Date : February 2009
Actual Primary Completion Date : December 2016
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pregnant women who have a foetus with a cleft lip/palate
Pregnant women who have a foetus with a cleft lip/palate
Other: Study of medical records
Study of medical records




Primary Outcome Measures :
  1. Compare the prenatal and postnatal diagnosis of cleft lip and palate [ Time Frame: At birth ]
    Compare the prenatal and postnatal diagnosis of cleft lip and palate


Secondary Outcome Measures :
  1. Study the cleft palate diagnosis when cleft lip is present [ Time Frame: At birth ]
    Study the cleft palate diagnosis when cleft lip is present



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Fœtus with cleft lip diagnosed at mid-trimester ultrasound screening in Montpellier hospital (Arnaud de Villeneuve) between February 2009 and December 2016.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582111


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Cyrielle LEFEBVRE, Midwife University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03582111    
Other Study ID Numbers: RECHMPL18_0284
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Ultrasound
Pregnancy
Diagnosis
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities