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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Christy
Burden
+44 (0)1179289000
christy.burden@bristol.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Hypertensive disorders in pregnancy
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Every year in the UK, there are 25,000 pregnancies complicated by pre-eclampsia, 3000 stillbirths and 60,000 preterm births. Pre-eclampsia is a complication of pregnancy that can lead to serious long-term health problems for women and pregnant people and their children. Severe pre-eclampsia can be fatal to both mother and baby. Stillbirth is the death of a baby after 24 weeks gestation before or during birth. Preterm birth is when a baby is born before 37 weeks of pregnancy. The number of complications that occur varies from hospital to hospital, which may be due to differences in care provided for women and pregnant people.
We know that the families whose babies sadly die during pregnancy or birth carry that devastation forward for life. It can have an impact on the whole family, future choices and future pregnancies, relationships, and mental health. Stillbirth is not only a tragedy at the time, but a tragedy for a lifetime for families.
Preterm birth is responsible for the greatest number of deaths in children under the age of 5 years. We know that babies born premature may be vulnerable to problems. The earlier in the pregnancy a baby is born, the more vulnerable they are. It is possible for a baby to survive if born around 24 weeks of pregnancy onwards. Babies born this early need special care in a hospital with specialist facilities for premature babies, called a neonatal unit (NICU). The baby may have health and development problems because they have not fully developed in the womb. Some of these problems may be long-lasting and affect the child’s quality of life. The impact of having a baby cared for in the NICU can be far-reaching. In the early days, the loss of the final trimester of pregnancy can result in feeding difficulties, anxiety of family disconnection, concerns about survival and long-term health outcomes, difficult decisions, feelings of hopelessness, financial pressures, and challenges learning to care for a tiny baby and becoming a parent in the NICU setting. The impact of preterm birth can last for years if there are long-term health issues. Mothers and birthing people of preterm infants have a higher chance of perinatal mental illness around the time of the birth.
There are three reasons why these pregnancy problems remain so common:
1. It is hard to identify which women are most likely to develop these complications, meaning that problems may develop unnoticed.
2. Risk assessment is often based on previous pregnancy outcomes, meaning that many parents must experience complications before receiving specialist care.
3. NHS maternity staff struggle with lack of resources and it is hard for them to ensure they are using the latest national guidelines to provide the best care.
The Tommy’s National Centre for Maternity Improvement has developed the Tommy’s Pathway: a Clinical Decision Support Tool for use by women and pregnant people, midwives and doctors. The Clinical Decision Support Tool is provided as a web application which means it is accessed via an internet browser just like any other website, using either a desktop computer, laptop, smartphone or tablet (any device with access to the internet).
We aim to investigate whether the tool will reduce pre-eclampsia, stillbirth, and preterm birth by improving how we identify those at risk of these problems and then providing healthcare professionals with current national guidance on the best care to offer women and pregnant people.
This project includes a trial of The Tool, which is made up of a number of assessments which help to identify potential issues for women and pregnant people. These assessments have been demonstrated to be effective in other studies, but this trial will test the Tool as a whole package in a number of NHS hospitals across England. We will compare the number of women and pregnant people with pregnancy problems who have had care from hospitals using the Tool, with those not using the Tool. The results will help the NHS decide if the Tommy’s Pathway: a Clinical Decision Support Tool reduces the number of pregnancy problems, and improves outcomes for mother and babies, and also if it saves the NHS money. If it does, its use will be recommended in all hospitals across the UK.
For health professionals to provide the best care for patients, randomised studies are needed to find out if treatments work. A randomised study involves assigning patients by chance to the treatment of interest, or to usual care, so that the effect of the treatment can be compared fairly. In this study, the whole hospital is randomised to deliver one intervention while another hospital will deliver standard care, to reduce the likelihood of patients being treated with a mixture of both interventions.
This study will aim to involve 62,400 NHS women and pregnant people in maternity units in England.
Half of the hospitals will use the Clinical Decision Support Tool to calculate the risk of pregnancy problems and provide associated care pathways, and half will carry on providing the care they offered before. All other aspects of care will be the same as the standard care provided by the hospital. Data will be collected on all women and pregnant people from the initial booking appointment until 28 days after the end of their pregnancy. Data will be collected from routinely collected hospital maternity records for both intervention and control units.
A specially gathered group of women, including those with lived experience of preterm birth, stillbirth and neonatal death and those without, have co-designed and developed the Tool from inception. To make sure the views of women are central to the way the study is done, PPI input involving women with lived experience and without will be sought through regular meetings during the set-up, delivery and dissemination of the results. Two patient representatives will sit on the Trial Steering Committee.
Our aim is to help make the UK the safest place in the world to give birth by improving women and pregnant people’s access to best care and reducing the variations in care offered around the country.
If the Clinical Decision Support Tool is effective, it will be rolled out to other hospitals to reduce rates of pre-eclampsia, preterm birth and stillbirth across the UK. It will also be translated into non-English languages. We will make sure that the findings reach all the people who can benefit from them in a suitable format. This includes plain English summaries for the public and customised material for other people such as health professionals and NHS Trust managers. The Tommy’s Centre for Maternity Improvement, with the support of the Royal Colleges, the Department of Health and Social Care and NHS England, will lead on developing plans for integrating the Clinical Decision Support Tool into all maternity care services.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Trust unwilling to participate2. Trust using (or planning to use) the Fetal Medicine Foundation algorithm as part of their formalised standard care pathway
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Christy
Burden
+44 (0)1179289000
christy.burden@bristol.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Bristol and funded by NIHR NHSX Artificial Intelligence Award.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 59197
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
