Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia

Pierre Robin Sequence Clinical Trial

Official title:

Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia : Prenatal Cephal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422067
• Other study ID #: RECHMPL20_0295
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be present at birth. After birth, the diagnosis of retrognathia is based on the clinical examination. Cephalometry can be used to complete the diagnosis. Several authors have proposed the use of objective quantitative ultrasound parameters for the antenatal screening of PRS. In our study, the investigators evaluated fetal cephalometry.

The aim First, the investigators studied the inter- and intra-observer reproducibility of cephalometry. Second, the investigators established reference values for antenatal cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance of cephalometry and the other angles described in the literature for the diagnosis of retrognathia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 30, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

Inclusion criteria:

• Pregnant patient (Aged >18years old)

• with one or more fetuses suffering from a microretrognathia

• diagnosed prenatally

• integrated into a Pierre Robin Sequence

Exclusion criteria:

• Uncvertain diagnosis

• Absence of 3D rendering volume

Related Conditions & MeSH terms

• Pierre Robin Sequence
• Pierre Robin Syndrome

Intervention

Other:
• Fetal cephalometry
Fetal cephalometry

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	Reproducibility of cephalometry	Reproducibility of cephalometry	During ultrasound
Secondary	Perfomance of several angle to diagnose retrognatism	Perfomance of several angle to diagnose retrognatism	During ultrasound