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

NCT04422067 | Completed

• 1 other identifier: RECHMPL20_0295
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pierre Robin Sequence

Keywords

with one or more fetuses suffering from a microretrognathia; Cephalometry; Prenatal Diagnosis; Facial angles; Fetal echography; Microretrognathia; diagnosed prenatally

Outcome Measures

Primary Outcomes (1)

• Reproducibility of cephalometry

  Reproducibility of cephalometry

  During ultrasound

Secondary Outcomes (1)

• Perfomance of several angle to diagnose retrognatism

  During ultrasound

Study Arms (2)

Case group (Retrognatism)

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.

Other: Fetal cephalometry

Control group

47 pregnant patients with fetus without facial abnormalities

Other: Fetal cephalometry

Interventions

Fetal cephalometry OTHER

Fetal cephalometry

Case group (Retrognatism); Control group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant patients with one or more fetuses suffering from a microretrognathia, diagnosed prenatally and integrated into a Pierre Robin Sequence

You may qualify if:

• Pregnant patient (Aged \>18years old)
• with one or more fetuses suffering from a microretrognathia
• diagnosed prenatally
• integrated into a Pierre Robin Sequence

You may not qualify if:

• Uncvertain diagnosis
• Absence of 3D rendering volume

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Pierre Robin Syndrome

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Florent FUCHS, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: May 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 30, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

FR (1)