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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

Tracking Information
First Submitted Date June 27, 2018
First Posted Date July 10, 2018
Last Update Posted Date July 11, 2018
Actual Study Start Date February 2009
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 27, 2018)
Study the cleft palate diagnosis when cleft lip is present [ Time Frame: At birth ]
Study the cleft palate diagnosis when cleft lip is present
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultrasound Diagnosis of Cleft Lip and Palate
Official Title Ultrasound Diagnosis of Cleft Lip and Palate - FENCHU
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Cleft Lip and Palate
Intervention Other: Study of medical records
Study of medical records
Study Groups/Cohorts Pregnant women who have a foetus with a cleft lip/palate
Pregnant women who have a foetus with a cleft lip/palate
Intervention: Other: Study of medical records
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2018)
200
Original Actual Enrollment Same as current
Actual Study Completion Date May 2018
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 46 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03582111
Other Study ID Numbers RECHMPL18_0284
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: NC
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Investigators
Principal Investigator: Cyrielle LEFEBVRE, Midwife University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date June 2018