3D Animation and Models to Aid Management of Fetal CDH

NCT03750266 | Recruiting

• 1 other identifier: STH19783
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Diaphragmatic Hernia

Outcome Measures

Primary Outcomes (1)

• Patient demographics

  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.

  Baseline

Study Arms (1)

Congenital Diaphragmatic Hernia referred for fetal MRA

Other: No intervention data collected through routine scans

Interventions

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.

Congenital Diaphragmatic Hernia referred for fetal MRA

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women whose fetus had a CDH and are referred to MRI.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Jessop Wing Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: November 23, 2018
• Study Start: October 4, 2017
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)