Study of Late-foetal Human Organ Development
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Congenital Disorders. Basic parameters: from 18 years · All.
- 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 →
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Overview
Knowledge about abnormal organ development is important to understand pathology and to develop novel treatment approaches for individuals with congenital and acquired disease. Most of our current understanding is based on examination of tissues from the embryo and early fetus, collected from women undergoing termination of pregnancy in the first trimester (third) of pregnancy. There is very little known about normal and abnormal organ development from a developmental perspective during the crucial last two-thirds of pregnancy when much remodelling of fetal tissues occurs. We aim to collect tissue from a variety of developing fetal organs in the last two-thirds of pregnancy from women who decide to undergo a termination of pregnancy and who wish to undergo a clinical fetal postmortem (PM) examination.
Primary outcome measures
- Cellular maturity [Time frame: Immediately after tissue collection]
Eligibility criteria
Inclusion criteria
- ≥18 years old pregnant women who attend the Fetal Medicine Unit for concerns about a fetal abnormality where they decide to proceed to termination of pregnancy
Exclusion criteria
- Screening labs positive for maternal HIV, Hepatitis B and Hepatitis C, Chlamydia and Herpes.
- Subject unable to make an informed decision about termination of pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
United Kingdom · 1 center
- University College Hospitals NHS Foundation Trust — London
Identifiers
NCT: NCT04661059 · 253088