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Recruiting NCT03750266

3D Animation and Models to Aid Management of Fetal CDH

Observational Congenital Diaphragmatic Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention data collected through routine scans.
Who it may be relevant to
Registry conditions: Congenital Diaphragmatic Hernia. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Role of 3D Images and Models to Aid Management of Cases of Congenital Diaphragmatic Hernia Diagnosed in the Antenatal Period. Consecutive Patients Studied From Diagnosis to Post Operative Period.

Overview

We wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH. This will both help the parents see what the problem is and also allow the surgeons, who will operate on the baby once it has been born, to see the size of the hole and what organs are in the wrong place.

Interventions

  • Other No intervention data collected through routine scans
    No intervention, we wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH.

Primary outcome measures

  • Patient demographics [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Target Population: pregnancy women attending Jessop Wing Fetal medicine unit.
  • Accessible population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI.
  • Study population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI and agree to take part in the study.

Exclusion criteria

  • Not able to give informed consent due to any reason including poor understanding of English
  • Under 18 years of age.
  • Unable to complete the fetal MRI process due to either metal implants or claustrophobia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Jessop Wing Hospital — Sheffield

Identifiers

NCT: NCT03750266 · STH19783

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗