Ultrasound Diagnosis of Cleft Lip and Palate (FENCHU)

Ultrasound Diagnosis of Cleft Lip and Palate - FENCHU

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.

Study Overview

• Status: Completed
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Other: Study of medical records

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 46 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the cleft palate diagnosis when cleft lip is present	Study the cleft palate diagnosis when cleft lip is present	At birth

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Cyrielle LEFEBVRE, Midwife, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Pregnancy; Diagnosis
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: RECHMPL18_0284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No