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Recruiting

NCT Number: NCT03750266

3D Animation and Models to Aid Management of Fetal CDH

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Jessop Wing Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location status: Recruiting

Location contact

Elspeth Whitby

CONTACT

[email protected]

0114 2261081

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

No intervention data collected through routine scans

Other

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 outcomes

  1. Patient demographics

    Time frame: Baseline

    Gestational age at time of scan and health outcomes from patient notes. This will be used to assess the accuracy of the 3D models developed.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Nov 23, 2018
Registry last updated
May 16, 2025

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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