RecruitingOBSERVATIONAL

The Tommy's National Rainbow Clinic Study

This study, called 'The Tommy's National Rainbow Clinic Study', is about improving care for parents who have experienced the heartbreaking loss of a baby. In the UK, over 4,000 families each year go through the death of a baby before or shortly after birth. These parents often feel anxious in their next pregnancy and need special support. 'Rainbow Clinics' offer this specialist care, and this study is evaluating how well they work across the UK. We want to understand women's experiences, their feelings of anxiety and sadness, and the health outcomes of their pregnancies. By collecting this information through questionnaires, we can identify areas for improvement and make sure these vital clinics provide the best possible support for families.

At a glance

Status

Recruiting

Sponsor

University of Manchester

Enrolment target

500

Start

01 Dec 2020

Estimated completion

30 Sep 2027

Stillbirth

What is this study about?

When a baby dies before or shortly after birth, it's an incredibly difficult time for parents. Many parents who experience this loss will become pregnant again, often quite soon after. Understandably, during these new pregnancies, they often feel very anxious and concerned about their baby's health.

Our research suggests that special support from doctors and midwives can really help these parents. This led to the development of 'Rainbow Clinics', which are designed to give dedicated care and emotional support to families who have suffered the heartbreak of losing a baby. The first Rainbow Clinic started in Manchester, and now the team is working to open more of these clinics in maternity units across the UK.

This study is designed to carefully look at the care provided by these new Rainbow Clinics. We want to understand how well they are working by gathering information on women's experiences, how they feel emotionally (including any anxiety or sadness), and how their pregnancies turn out. By doing this, we can figure out what's going well and where we can make improvements, ensuring these clinics offer the best possible support to families at such a sensitive time.

Key takeaways

This study evaluates special 'Rainbow Clinics' for parents who have lost a baby.
It aims to improve care and support for mums in subsequent pregnancies.
You participate by completing two short questionnaires during pregnancy.
Information on your pregnancy outcome will also be collected.
Your care will not be affected by your decision to join or not.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to women who are currently pregnant and have been referred to a Rainbow Clinic.

To be eligible, you must have previously experienced a stillbirth (your baby died before birth), a neonatal death (your baby died shortly after birth), or a late termination of pregnancy.

Unfortunately, you wouldn't be able to join if you are under 16 years old or if you are unable to understand what it means to take part and give your permission.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you currently pregnant?
Have you experienced a stillbirth, neonatal death, or late termination of pregnancy before?
Are you attending a Rainbow Clinic for your current pregnancy?
Are you 16 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be invited to complete two short questionnaires. The first questionnaire will be given to you early in your pregnancy, and the second one will be completed towards the end of your pregnancy. These questionnaires will ask about your experiences of the care you're receiving at the Rainbow Clinic, as well as your feelings and emotions, such as anxiety or sadness.

The study will also collect information about how your pregnancy progresses and the outcome of your baby's birth. This information will primarily come from your medical records, so you won't need to provide it yourself directly. The total duration of your participation will be from when you complete the first questionnaire until after your baby is born and the pregnancy outcome information has been gathered. There are no additional visits to make beyond your usual Rainbow Clinic appointments, and you won't be asked to take any new medications as part of this study.

Potential risks and benefits

A potential benefit of taking part is contributing to a better understanding of how Rainbow Clinics can best support families, ultimately helping to improve care for others in the future. There are no direct medical risks from participating, as it mainly involves completing questionnaires and allowing the study to gather information about your pregnancy. Some questions might bring up difficult emotions, but you are always free to skip any questions you don't wish to answer. It's important to remember that you can decide to stop taking part in the study at any time, without giving a reason, and this will not affect the care you receive.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Manchester University NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is a 'Rainbow Clinic'?

A Rainbow Clinic provides specialist care and support for parents who have experienced the loss of a baby during a previous pregnancy.

Why is this study being done?

The study aims to understand how well the Rainbow Clinics are working, what women think of the care, and if it helps reduce anxiety, so we can make improvements.

Will taking part affect my medical care?

No, your decision to participate or not will not affect the care you receive from your doctors and midwives.

What do I need to do if I join?

You'll be asked to complete two short questionnaires during your pregnancy. The study will also collect information about your pregnancy outcome from your medical records.

Can I stop participating if I change my mind?

Yes, you are completely free to withdraw from the study at any time without needing to give a reason.

How to find out more

Alexander E Heazell, PhD

alexander.heazell@manchester.ac.uk +441612766484 Official trial record

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