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

Completed

• Conditions: Pierre Robin Sequence
• Interventions: Other: Fetal cephalometry

• Registration Number: NCT04422067
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Last Update Submitted: 2020-06-08
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group (Retrognatism)	Fetal cephalometry	All pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence, were included. All cases were confirmed postnatally, either by a pediatric examination or by a fetopathological examination in the case of a medical termination of the pregnancy. We had 21 cases.
Control group	Fetal cephalometry	47 pregnant patients with fetus without facial abnormalities

Primary Outcome Measures

Name	Time	Method
Reproducibility of cephalometry	During ultrasound	Reproducibility of cephalometry

Secondary Outcome Measures

Name	Time	Method
Perfomance of several angle to diagnose retrognatism	During ultrasound	Perfomance of several angle to diagnose retrognatism

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France