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

NCT ID: NCT04422067

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-09-30

Brief Summary

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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

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Conditions

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Pierre Robin Sequence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Fetal cephalometry

Intervention Type OTHER

Fetal cephalometry

Control group

47 pregnant patients with fetus without facial abnormalities

Fetal cephalometry

Intervention Type OTHER

Fetal cephalometry

Interventions

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Fetal cephalometry

Fetal cephalometry

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florent FUCHS, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0295

Identifier Type: -

Identifier Source: org_study_id

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