Closed research trials and results

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 study has now closed and we await the results. 

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

The study has now closed and we await the results. 

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 study has now closed and we await the results. 

The ABA-feed study (Maternity)

ABA-feed was a study offering extra support to women with feeding their baby.

New parents often have questions about feeding their baby and welcome extra support and advice. We wanted to compare two different ways of providing support for infant feeding. Those taking part in the study were divided, at random, into two groups – usual care or ABA-feed. One group received the usual information and support provided for feeding their baby from their midwife, health visitor and other available voluntary groups (‘usual care’). The other group received the same usual care but were also offered additional support before and after their babies were born from a specially trained ABA-feed Infant Feeding Helper.

This popular study has just closed, and we await the results with interest

PPHSAT – Perinatal Pelvic Health Self-Assessment Tool (Maternity)

This study asked for help from pregnant and postnatal women to complete questionnaires about their pelvic health [pelvic organs e.g., bladder, bowel, and vagina]. The aim of the questionnaire was to raise awareness and identification of symptoms and improve referrals to specialists. The study was about the design of the questionnaire and how it works in practice not on the medical findings of the participant, but this will help us to improve healthcare services provided to women in the future. Results will be shared in due course.

The Sunny Study (Maternity)

This study tested a new approach to helping people become more physically active during pregnancy.

Guidelines state that pregnant women should complete at least 150 minutes of moderate to vigorous intensity physical activity every week, this includes activities such as walking briskly, climbing stairs, and carrying shopping bags. Physical activity can have important health benefits for pregnant women such as reducing their risk of gaining more weight during pregnancy than recommended, decreasing feelings of anxiety and depressive symptoms, improving sleep, and can help to reduce lower back pain. However, many pregnant women find it difficult to be physically active during pregnancy and spend a lot of time sitting. This study aimed to explore two different approaches to helping pregnant women be physically active and we await the results with interest.

The CRAFT Project (Maternity)

This study was an investigation into the role of previous in-labour caesarean section in future preterm birth risk and potential management strategies. Worldwide, there is a 9.6% rate of preterm birth before 37 weeks. The timing of preterm birth is directly related to the amount of risk to the infant at birth and for his/her long-term health.

There are multiple factors which predispose women to preterm birth such as surgery to the neck of the womb, previous preterm birth and multiple pregnancies. A new factor now found to be contributing to this risk is if the mother has had a previous full dilatation caesarean section (FDCS) in labour. 

Recent studies have shown that if a woman has an emergency caesarean section in one pregnancy (particularly when the cervix or neck of the womb is fully or nearly open) she is at higher risk of having a premature baby or ‘late’ miscarriage (a miscarriage after 14 weeks of pregnancy) in a future pregnancy. However, we do not know how many women this is likely to affect. So, this study aimed to answer those questions and we look forward to the results that will help clinicians give the best advice to women making these important decisions.

Preg – Cov Study (Maternity)

Towards the end of 2019 and beginning of 2020, a new virus subsequently named SARS-CoV2, emerged and was found to cause a disease called COVID-19. The virus has spread across the world causing a pandemic. Almost simultaneously, work began on developing vaccines against this virus with the aim of helping prevent severe disease, hospitalisation and death.

In this trial, we aimed to gather further specific data on the safety of COVID-19 vaccines in pregnant women and their babies. We also compared the immune responses to different COVID-19 vaccines in pregnant women and their babies and looked at whether the stage of pregnancy and the intervals between vaccine doses made a difference. The study was also determining the optimal dose of a booster COVID-19 vaccine in pregnancy and whether COVID-19 vaccines can be given at the same time as the routine whooping cough vaccines in pregnancy.

Results of study pending.

The OptiBreech Trial (Maternity)

Most babies are born head-first, but about 1 in 25 are bottom-down (breech) after 37 weeks of pregnancy. Women who wish to plan a vaginal breech birth have asked for more reliable support from an experienced professional. This aligns with national policy to enable maternal choice. In this study, we explored the feasibility of evaluating a new care pathway for women with a breech pregnancy. OptiBreech care included specialist leadership, evidence-based training, and an active birth approach if a vaginal birth was planned.

This study has now closed to recruitment, but the specialist leadership team remain to support women who choose an active birth approach in these circumstances.

LION MenB (Neonatal)

This study was done to compare two different primary immunisation schedules for Meningococcal B disease in infants.

In 2015, the United Kingdom became the first country in the world to introduce the meningococcal group B (Men B) vaccine into its routine schedule for infants. This vaccine has proved to be very effective in protecting against meningitis (infection of the lining of the brain) and septicaemia (blood poisoning) caused by a subgroup (group B) of the meningococcus germ. In the United Kingdom, babies are offered this vaccination at 2, 4 and 12 months.

Here at RCHT, we joined with other centres to compare two different schedules of Men B vaccination, the standard schedule (at 2, 4 and 12 months) and the early schedule (at 2, 3 and 12 months). We wanted to know if receiving the first two doses of Men B vaccine by 3 months could provide infants earlier protection against Men B disease.

We are now waiting for the results.

Results of past studies

Once a study has completed, it can take some months or even years, for results to be analysed, discussed, shared, and reported. The following studies closed some time ago now, but we are anticipating results soon that will help give you the best quality care, treatment, and advice if you experience these circumstances of pregnancy and childbirth.

Pending results

• Big Baby – this study was looking at the best time to deliver a bigger baby. (Maternity)
• WILL – this study was looking at the best time to deliver babies in those women who had a raised blood pressure. (Maternity)

POOL study results

The POOL Study run by Cardiff University aimed to answer some of the questions about the safety of water births for mothers and their babies.

The study included data about births attended by midwives from 26 NHS units around the UK. This included all births attended by midwives at home and in midwifery led units as well as births in the main obstetric unit in 26 participating NHS sites, between 2015 and 2022.

Overall, the POOL study found that water births in the UK are just as safe for mothers and their babies as giving birth out of water.

For more detailed information about what this means for you, please see the Cardiff University ‘Using a POOL during labour and birth’ PDF, or scan the QR code.