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What is maternity research?

At Royal Cornwall Hospitals, we carry out research to gather evidence on what works in maternity services so that we can deliver the best possible care for women, children and their families – now and in the future.

Clinical research is, and always has been, at the very heart of the NHS. Only by carrying out research into “what works” can we continually improve drugs, treatments and care pathways for patients, and understand how to focus NHS resources where they will be most effective.

There is also evidence that shows that just being in a research study can improve a persons’ outcomes, and sometimes being in a study can give access to treatments that otherwise might not be available for a few years.

Find out more about clinical trials in the ‘Understanding clinical trials’ leaflet produced by NHS National Institute for Health Research.

What we are all about

Our dedicated team of research Drs, midwives, nurses and research support staff understand the importance of evidence-based practice and are well placed to recognise opportunities for improvement in patient care.

We are working closely with Cornwall’s Research and Innovation team and the NIHR Clinical Research Network for the Southwest, who fund the research midwife posts at Cornwall’s Hospital.

Working collaboratively with the wider research team here at RCHT, the midwifery research team recruit to midwifery, obstetric and neonatal research studies to add to our body of knowledge and improve patient care across the county.

This site will introduce you to our maternity, obstetric and neonatal studies, but as a team we also support wider paediatric and gynaecological studies not detailed here. If you are interested in taking part in any of these studies, then please contact the Kensey Research Team here at the Royal Cornwall Hospital and we can have a chat about which studies are appropriate for you.

So, why is research important?

Research means we can:

• develop new and better treatments
• be better at preventing problems and making a quick diagnosis
• give you the best care

We want to ensure that the care of future generations of mothers and babies is even better than the care we give now. The way we can do this is by participating in research trials and studies and you are a key part of helping us do this.

Research can only happen with your help. Please join us!

Contact us

• Kensey Team Research Office: 01872 255177 [answer machine service out of hours]
• Research Mobile: 07785 449262 [please phone or text]
• Email us: rch-tr.researchmidwives@nhs.net

Current Trials

Studies may run for many years and other studies may only be open to recruitment for a few months. 

Here we describe  the studies that are currently open to recruitment in our maternity and newborn and neonatal departments  at Royal Cornwall Hospitals. There are studies coming through all the time, so please contact us for more information and details of what we are looking forward to.

In line with the principles of Good Clinical Practice in research, participation in any research study is always voluntary and if you take part in a study but then later change your mind, you can withdraw from the study at any time without giving a reason and without your care being affected in any way.

We look forward to hearing from you.

The Giant PANDA Trial – Hypertension (Maternity)

Why?

Approximately 70,000 pregnant women per year (8-10% of UK pregnancies) have hypertension or high blood pressure in pregnancy. This includes chronic (pre-existing, typically essential) and gestational (new after 20 weeks’ gestation) hypertension and pre-eclampsia (hypertension with additional features of multiorgan involvement). 

High blood pressure increases the risk of harm to the mother and to her baby. 

The evidence base for choosing antihypertensive treatment in pregnancy is limited. The Giant PANDA study wants to look at the two most commonly used medications (Labetalol and Nifedipine) to treat high blood pressure in pregnancy. Doctors in the NHS usually choose one or the other as their preferred treatment.

The Giant Panda study wants to find out which is best at treating blood pressure in pregnant women without having troublesome side-effects for the woman or baby.

What is involved?

Once you have signed the consent form, details about you and your pregnancy will be put into a computer which will randomly choose for you one of two antihypertensive medications. (Nifedipine or Labetalol)

Who is it for?

The Giant Panda study is looking to enrol pregnant women up to 34+6 gestation weeks who have high blood pressure (hypertension) prior to pregnancy (chronic hypertension) or who have high blood pressure in pregnancy (gestational hypertension) and pre-eclampsia. 

To find out more: 

• Giant Panda Patient Information Leaflet / PIS
• Visit the University of Birmingham’s Giant Panda Trial page

Recruiting until June 2024 

If you are interested in taking part, please contact us

Research Midwives, Kensey Team

• 01872 255177 [out of hours answering machine available]
• 07785 449262 [please phone or text]
• Email: rch-tr.researchmidwives@nhs.net

The iHOLDS Study – Induction of Labour (Maternity)

Why?

About 34% of (or one in three) first time mothers have their labour induced. Labour induction is the process we use to start labour artificially. The drug used to help start labour is oxytocin and we want to find out if increasing the dose of oxytocin will reduce the chances of a woman requiring a caesarean section.

What is involved?

Once you have signed the consent form, details about you and your pregnancy will be put into a computer which will randomly choose which dose of the drug you will receive and both you and your baby will be monitored closely whichever you receive. While neither you nor your baby will need any extra tests or visits, we will be asking you to fill in a short multiple-choice questionnaire about two weeks after your baby’s birth with some simple questions to find out how the birth experience was for you. You can choose whether you complete the Maternal Satisfaction Questionnaire on your smart phone, by email or we can send it in the post to you.

Who is it for?

For women and birthing persons who require induction of labour. Labour induction may be required for a variety of reasons, most commonly because a pregnancy may have gone past the due date, or because waters have broken but labour contractions have not yet started.

To find out more: 

• Visit the University of Birmingham’s iHOLDS page

If you are interested in taking part, please contact us

Research Midwives, Kensey Team

• 01872 255177 [out of hours answering machine available]
• 07785 449262 [please phone or text]
• Email: rch-tr.researchmidwives@nhs.net

Empirical oral Antibiotics for possible urinary tract infection (UTI) in well appearing Young febrile infants.

Why?

Children between 1 and 3 months of age with a fever (raised body temperature) commonly undergo blood and urine tests to check for infection. They are admitted to hospital for a minimum of 2 days to wait for results of their lab tests for infection and given injected antibiotics “just in case” while waiting for these results.

Lab tests for infection involve watching to see if bacteria grow in blood and urine samples over a period of 2 days. As well as these slow tests for infection, babies will usually also have some rapid tests done on a blood sample (that take about one hour) which are used to help assess how unwell a baby is.

The most common bacterial infection in babies aged 1 to 3 months is a urinary infection. As many as 1 in 5 babies with a fever have a urinary infection. These infections are not as serious as sepsis or meningitis but can be difficult to diagnose. When doctors are unsure if there is a urine infection they usually give injected antibiotics until the results of lab tests for infection are available 2 days later.

Lots of research has shown that babies aged between 1 and 3 months who appear well have and have reassuring results from the rapid blood tests are at very low risk of developing dangerous infections like meningitis or sepsis.

Therefore, because the vast majority of these low risk babies do not have a serious infection, they receive more intensive treatment than they need when they are admitted for injected antibiotics just in case .

The aim of this research is to determine if babies with suspected urinary infection who are at low risk of dangerous infections can safely be treated with oral antibiotics whilst they wait for their lab results.

This approach has the potential to reduce the need for painful procedures such as injections, reduce hospital admissions with its associated stress for family/carers and also reduce healthcare costs.

What is involved?

The study is going to compare oral antibiotics with injected antibiotics whilst waiting for culture results. Families won’t be able to choose which treatment they receive. To make things fair, this will be decided using computer software through a process called randomisation. Parents will be asked to report the child’s symptoms and ability to take the prescribed medications.

Who is it for?

For infants between 1 and 3 months of age with a fever (raised body temperature) who are admitted to hospital for antibiotics.

If you are interested in taking part, please contact us

Research Midwives, Kensey Team

• 01872 255177 [out of hours answering machine available]
• 07785 449262 [please phone or text]
• Email: rch-tr.researchmidwives@nhs.net

The neoGASTRIC Study – Premature Baby Feeding (Neonatal)

This neonatal unit is taking part in an important research study called neoGASTRIC which is comparing care practices that already take place in neonatal units across the United Kingdom (UK). We plan to include every eligible baby in the study unless you tell us you do not want your baby to take part (opt out).

Why?

Premature babies aren’t always able to suck and swallow their milk. That’s why they are fed milk every few hours through a soft tube which lies in their stomach. The tube is called a ‘gastric tube’ and is placed via the nose or mouth.

When a baby has a gastric tube in, some doctors and nurses routinely measure gastric residual volumes – checking to see how much milk is left in the baby’s stomach before the next feed. Some doctors and nurses routinely measure gastric residual volumes because they think it might help tell if the baby is coping with their feeds and may help identify signs of a serious but rare gut disease called necrotising enterocolitis (NEC). Other doctors and nurses think that routinely measuring gastric residual volumes may not be a good idea because it can be inaccurate, and we do not know if it does help to identify necrotising enterocolitis (NEC).

In the UK about half of doctors and nurses routinely measure gastric residual volumes and about half don’t – so both approaches are standard treatment. So, to check whether or not routinely measuring gastric residual volumes is safe or harmful we need to collect information on thousands of premature babies. The neoGASTRIC study will answer this question by comparing babies who have routine gastric measurements with those who do not to see if they can reach full feeds quicker without increasing their chance of getting necrotising enterocolitis (NEC).

Who is it for?

The neoGASTRIC study is for babies born more than 6 weeks early and needing a feeding tube.

To find out more:

• neoGASTRIC Parent Information Sheet (Imperial College London)

If you are interested in taking part, please contact us

Research Midwives, Kensey Team

• 01872 255177 [out of hours answering machine available]
• 07785 449262 [please phone or text]
• Email: rch-tr.researchmidwives@nhs.net

neonINand neoAMRO Studies – Infection Surveillance in Babies (Neonatal)

Our Neonatal Unit is part of a network of neonatal units, which contribute information on infections to a central database (neonIN).

• Neonatal Infection Surveillance Network: neonIN – trial recently extended
• Neonatal Antimicrobial Resistance and Outcome: neoAMRO – trial recently closed to further recruitment

What?

These are both surveillance studies aiming to capture information about infections in newborn babies who are admitted to a neonatal unit that will help us improve the way we identify, treat, and manage infections in the future.

Infection in newborn babies is common yet until now there has been no detailed and on-going collection of information about infections in the UK. Such information can tell us which the most common infections are, what factors make these infections more likely and which antibiotics are best for treating them.

The database will allow this information to be gathered and analysed easily and ensure that the information is up to date.

What does it mean for my baby?

Unless you specifically object, basic information about your baby will be stored by one of your doctors on a database. They will use a code number; no names or addresses are attached to the results. Your child cannot be identified from the information kept on the database. If you would prefer that this does not happen, please tell your doctors. Declining to take part will not affect or alter any decisions about your baby’s care or treatment.

Who is it for?

Infants on neonatal units who have an episode of infection with a positive culture.

To find out more:

• Visit the neonIN website