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Study of Late-foetal Human Organ Development

Sponsor
University College London Hospitals (Other)
Overall Status
Recruiting
CT.gov ID
NCT04661059
Collaborator
(none)
2,000
Enrollment
1
Location
226.9
Anticipated Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Study of Late-foetal Human Organ Development
    Actual Study Start Date :
    Feb 3, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Dec 31, 2040

    Outcome Measures

    Primary Outcome Measures

    1. Cellular maturity [Immediately after tissue collection]

      Immunofluorescence staining

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University College Hospitals NHS Foundation Trust London United Kingdom

    Sponsors and Collaborators

    • University College London Hospitals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marko Nikolic, Principal Investigator, University College London Hospitals
    ClinicalTrials.gov Identifier:
    NCT04661059
    Other Study ID Numbers:
    • 253088
    First Posted:
    Dec 9, 2020
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 24, 2022