ClinicalTrials.gg
RecruitingNCT03750266Updated Aug 7, 2026

3D Animation and Models to Aid Management of Fetal CDH

An observational study in Congenital Diaphragmatic Hernia, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational

From the registry’s dates

  • Started Oct 2017; still recruiting 9 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Congenital Diaphragmatic Hernia
03

In context

Hernias, Diaphragmatic, Congenital

86 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 20 observational studies indexed under Hernias, Diaphragmatic, Congenital.

Browse Hernias, Diaphragmatic, Congenital studies →

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 214 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Not able to give 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Congenital Diaphragmatic Hernia referred for fetal MRA

    Other: No intervention data collected through routine scans

Interventions

  • OtherNo 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.

06

What researchers measure

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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03750266
Responsible party
Sponsor
First posted
Nov 23, 2018
Start date
Oct 4, 2017
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 7, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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No contact was published for this record. The registry link below has the sponsor’s details.

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