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OpenTrials
Completed

NCT Number: NCT03582111

Ultrasound Diagnosis of Cleft Lip and Palate

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Lip Diseases Mouth Abnormalities Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year–46 year

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study of medical records

Other

Study of medical records

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Ultrasound Diagnosis of Cleft Lip and Palate - FENCHU

Acronym: FENCHU

Important dates

Study start
2009
Primary completion
2016
Study completion
2018
First posted
Jul 10, 2018
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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