RecruitingOBSERVATIONAL

Study of Late-foetal Human Organ Development

This study aims to understand how babies' organs develop normally and when things go wrong, especially in the later stages of pregnancy. Most of what we currently know comes from very early pregnancy, but much development and change happens later on. By learning more, researchers hope to find new and better ways to treat conditions that affect babies, both before they are born and later in life. The study involves collecting tissue samples from different developing organs of babies whose mothers have decided to have a termination of pregnancy and have also agreed to a hospital examination (post-mortem) of their baby.

At a glance

Status

Recruiting

Sponsor

University College London Hospitals

Enrolment target

2,000

Start

03 Feb 2022

Estimated completion

31 Dec 2040

Congenital Disorders

What is this study about?

This study is about understanding how a baby's organs grow and change during the later two-thirds of pregnancy. Doctors and scientists are keen to learn more about this because knowing how organs develop normally helps them understand why problems or conditions might happen. This knowledge is really important for finding new ways to help babies who have health issues, either from birth or later in life.

Currently, most of what we understand about organ development comes from studies done very early in pregnancy. However, the last two-thirds of pregnancy are a crucial time when a lot of important changes happen to a baby's organs. Because of this, there's a big gap in our knowledge about what happens during these later stages.

To bridge this gap, the study involves collecting small tissue samples from different organs of babies. This happens after a woman has made the difficult decision to have a termination of pregnancy and has also agreed for her baby to have a hospital examination (sometimes called a post-mortem). This allows researchers to carefully study the development of these organs. By looking at these tissues, scientists hope to gain a much clearer picture of how organs develop and what can lead to problems.

Key takeaways

Study aims to understand baby organ development in later pregnancy.
Contributes to finding new treatments for birth conditions.
Involves tissue samples after termination of pregnancy and hospital examination.
No extra procedures or changes to your care.
Participation helps future medical knowledge.

Who may be eligible?

To take part in this study, you must be a pregnant woman aged 18 or over. You would be considering having a termination of pregnancy because you have concerns about your baby's health, and you would be attending the Fetal Medicine Unit.

There are certain reasons why someone might not be able to join the study. This includes if routine blood tests show that you have certain infections like HIV, Hepatitis B or C, Chlamydia, or Herpes.

It's also very important that you are able to clearly understand the information about the study and are capable of making your own decision about participating. If this is not the case, you would not be able to join.

Quick self-check

Are you 18 years old or older?
Are you pregnant and considering a termination due to concerns about your baby's health?
Are you attending the Fetal Medicine Unit?
Do you feel you can understand the study information and make your own decision?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, your participation would involve providing consent for researchers to collect tissue samples from your baby after a termination of pregnancy and when a hospital examination (post-mortem) is taking place. There are no extra visits, assessments, or medications involved specifically for this study. The study would not change the process or care you receive for your termination or the post-mortem examination itself. The samples would be collected as part of the existing hospital examination process.

Potential risks and benefits

There are no direct medical benefits to you or your baby from taking part in this study. However, by donating tissue, you would be contributing valuable information that could help future babies and families by improving our understanding of organ development and potential treatments. There are no additional physical risks to you from taking part, as the tissue collection happens during a procedure you've already consented to. All information collected would be kept confidential. You have the right to withdraw from the study at any time, even after agreeing to take part, without it affecting your medical care.

Locations (1)

University College Hospitals NHS Foundation Trust
London, United Kingdom· Recruiting

Common questions

What is a 'termination of pregnancy'?

A termination of pregnancy is when a pregnancy is ended. It's a very personal and often difficult decision made for various medical or personal reasons.

What is a 'fetal post-mortem examination'?

This is a detailed hospital examination of a baby after a termination or a miscarriage. It helps doctors understand more about the baby's health and development.

Will taking part in the study change my care?

No, taking part in this study will not change the medical care you receive for your termination or the post-mortem examination.

Is my information kept private?

Yes, all your personal and medical information collected for the study will be kept confidential and private.

What does 'congenital disorders' mean?

Congenital disorders are health conditions or differences that are present in a baby from birth.

How to find out more

Sarah Gibbon

sarah.gibbon1@nhs.net +44 20 3456 7890 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.