Study of Late-foetal Human Organ Development

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Disorders

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Sarah Gibbon; Phone Number: +44 20 3456 7890; Email: sarah.gibbon1@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • University College Hospitals NHS Foundation Trust
    • Contact: Sarah Gibbon; Phone Number: +44 20 3456 7890; Email: sarah.gibbon1@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

As above

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular maturity	Immunofluorescence staining	Immediately after tissue collection

Collaborators and Investigators

• Sponsor: University College London Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 253088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No