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NCT04661059 Clinical Trial

Study of Late-foetal Human Organ Development

Congenital Disorders Clinical Trial

Official title:
Study of Late-foetal Human Organ Development

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04661059
Other study ID # 253088
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 3, 2022
Est. completion date December 31, 2040

Study information
Verified date December 2023
Source University College London Hospitals
Contact Sarah Gibbon
Phone +44 20 3456 7890
Email sarah.gibbon1@nhs.net
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 31, 2040
Est. primary completion date September 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom University College Hospitals NHS Foundation Trust London

Sponsors (1)
Lead Sponsor Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cellular maturity Immunofluorescence staining Immediately after tissue collection
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