NCT04661059

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
178mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Feb 2022Dec 2040

First Submitted

Initial submission to the registry

December 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 3, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
16.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Expected
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

2.7 years

First QC Date

December 1, 2020

Last Update Submit

December 4, 2023

Conditions

Congenital Disorders

Outcome Measures

Primary Outcomes (1)

  • Cellular maturity

    Immunofluorescence staining

    Immediately after tissue collection

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As above

You may qualify if:

  • ≥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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sarah Gibbon

CONTACT

+44 20 3456 7890sarah.gibbon1@nhs.net

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 9, 2020

Study Start

February 3, 2022

Primary Completion

September 30, 2024

Study Completion (Estimated)

December 31, 2040

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations

GB(1)