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OpenTrials
Completed

NCT Number: NCT04422067

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fetal cephalometry

Other

Fetal cephalometry

Primary outcomes

  1. Reproducibility of cephalometry

    Time frame: During ultrasound

    Reproducibility of cephalometry

Secondary outcomes

  1. Perfomance of several angle to diagnose retrognatism

    Time frame: During ultrasound

    Perfomance of several angle to diagnose retrognatism

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 9, 2020
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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