NCT03750266RecruitingNot Applicable
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.
Sheffield Teaching Hospitals NHS Foundation Trust1 site in 1 country30 target enrollmentStarted: October 4, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Patient demographics
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Congenital Diaphragmatic Hernia referred for fetal MRA
Intervention: No intervention data collected through routine scans (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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