WCH Research Unit Current Projects
Over the last 2 years we have recruited over 2,000 patients to participate in our research. For more information on individual projects please see the specific research study pages.
Antenatal Care Education: the co-design and piloting of interventions to improve patient and staff experience through better birth preparedness.
Many women have a very different birth experience to what they expected, which can contribute to anxiety and distress. Up to 1.5% of women experience post-traumatic stress disorder at six months following birth, and up to 50% of women suffer stress-related symptoms at two months after Caesarean section and 24% at six weeks after vaginal delivery.
Research has shown that having information about labour, birth and the postnatal period, and feeling in control during labour, are associated with positive psychological outcomes.
Some antenatal education is currently offered to women and their partners as part of routine care. However, many women do not attend these classes and the content and delivery is variable within and between areas.
ACE is a patient-focused intervention that will educate and support women to develop and use coping strategies. It will also equip the midwifery workforce at North Bristol NHS Trust to deliver interactive, skills-based education and enable them to better support patients.
The project aims to improve patient experience, psychological outcomes and staff satisfaction with care.
Focus groups will be held with women and staff to identify current expectations of labour and birth, and to understand how women would like to use coping strategies.
The two interventions (one for women; one for staff) will then be implemented in three community midwifery hubs. Around 50 women in each area will attend. Community midwives will deliver the intervention in addition to usual care. A project midwife will deliver the staff training intervention.
The study started on 01st January 2019 and will end on 31st March 2020.
This study is funded by The Health Foundation. Collaborators include: the University of Bristol and the National Childbirth Trust.
Study Contact: Chief Investigator, Dr Abi Merriel (firstname.lastname@example.org)
CHronic endometritis ANd unexplained reCurrent misscarriagE: the role of the endometrial microbiome
Background: Many people want to become parents. Unfortunately, 5% of couples experience recurrent miscarriage – defined as two or more miscarriages in a row. In more than half of these cases no cause is found.
This has a significant psychological impact on couples and uses many NHS resources. We do not know how to treat women with unexplained recurrent miscarriage and currently only offer supportive care.
A suggested cause of recurrent miscarriage is persistent inflammation of the womb lining. This is known as ‘chronic endometritis’. It may result in an unhealthy environment for an embryo. Chronic endometritis cannot be detected using regular tests; it requires examining a sample of the womb lining in a laboratory. Studies that previously investigated chronic endometritis as a potential cause of recurrent miscarriage are of poor quality and therefore National and International guidelines, The James Lind Alliance, and national miscarriage charities have prioritised this area for research.
Aim: To identify whether women with recurrent miscarriage are more likely to have chronic endometritis than women without recurrent miscarriage, and to identify any bacteria that might be responsible for chronic endometritis. Furthermore, we will investigate if chronic endometritis could cause recurrent miscarriage by changing the distribution/function of cells in the womb lining.
Methods: We will collect a sample of the womb lining from 100 women with a history of recurrent miscarriage and from 100 women who have had a successful pregnancy and no history of recurrent miscarriage (a control group). The control group (as approved by our patient advisory group) will be women undergoing planned “key hole” surgery for another reason but which allows easy sampling of their womb lining too.
If our study shows that chronic endometritis is a likely cause of recurrent miscarriage, we will carry out another study to see if treating chronic endometritis, with targeted antibiotics, increases pregnancy rates. Effective treatment would improve outcomes for our patients and save the NHS and society costs associated with recurrent miscarriage.
The study has been co-designed by women and their partners. Our patient advisory group will also be integral throughout the delivery of the study; from leading the preparation of patient facing documentation, to reviewing any changes made to the study protocol and co-dissemination of our findings through links with Tommy’s charity and The Miscarriage Association.
Sharing the results: Our findings will be presented through national miscarriage charity events and national and international medical conferences. Our results will be published in health journals and freely available to the public. We will work closely with the relevant NHS and professional organisations to ensure that our findings are meaningful and widely and appropriately disseminated.
The study started on 01st April 2019 and will end on 31st March 2021.
This study is funded by the National Institute for Health Research (NIHR). Collaborators include: the University of Bristol, University College London and the University of Birmingham.
Study Contact: Chief Investigator, Dr Islam Gamaleldin (email@example.com)
A double blind placebo controlled trial of a combination of methotrexate and gefitinib versus methotrexate alone as a treatment for ectopic pregnancy.
Ectopic pregnancy (EP) occurs when an embryo implants in a Fallopian tube. A methotrexate (MTX) injection causes serum pregnancy hormone [hCG] levels to fall and is a suitable treatment for stable EP. However, in 30% of women, MTX is unsuccessful (with surgery required); and in 15%, it is partially effective (2nd dose of MTX required); and for many women, treatment is prolonged (many hospital visits). We have performed studies giving MTX and gefitinib (lung cancer drug) to women with EP. We found that giving MTX and gefitinib together may reduce the need for surgery and hospital visits without causing any important side effects. These findings now require further study in a large trial and we need to understand how gefitinib works. We plan a clinical trial (‘main study’) to compare MTX and either a seven day course of gefitinib or placebo (dummy) tablets. We will assess whether the two drugs together are better at treating the EP without the need for surgery; reducing hCG levels, hospital visits and need for further MTX; and look at safety and patient satisfaction. Treatment response will be monitored according to local standard protocols. The study will recruit 328 women from ~50 UK hospitals. To examine how MTX and gefitinib affects the pregnancy tissue (‘mechanistic study’), we will also 30 women who opt to have their EP treated surgically to take medication preoperatively (gefitinib and MTX) and collect their EP tissues at time of surgery. We will also ask women in whom the treatment has failed and who require ‘rescue’ surgery for permission to collect their pregnancy tissues.
End date: 30/04/2019
Development of a core outcome set and identification of outcome measurement tools to improve care and research for care after stillbirth.
To develop a Core Outcome Set (COS) and identify outcome measurement tools to improve care and research after stillbirth.
Interventions or care offered to parents following the diagnosis of stillbirth include birthing options, counselling and care in subsequent pregnancies. The evidence for many of these interventions is limited. A scoping review investigating the outcomes reported in studies evaluating interventions after stillbirth, highlighted the wide variation in outcome reporting, with almost all researchers neglecting to involve parents in their decision making when considering what outcomes to measure.
There is a need to develop and evaluate evidence-based care for parents experiencing stillbirth. In order to ensure research focuses on outcomes that matter to parents and avoid research wastage, it is vital to establish a core set of outcomes which could be measured whenever a new or existing intervention or care is implemented. These outcomes would need to be feasible, acceptable and reliable to key stakeholders including parents, healthcare professionals and researchers. A core outcome set for care after stillbirth will ultimately lead to more efficient research and better care, faster, for parents.
Stage 1: Identifying previously reported outcomes
A systematic review of the quantitative and qualitative literature is being undertaken to investigate what outcomes have been reported in existing studies and what measurement tools have been used to measure those outcomes.
Stage 2: Identifying outcomes that are important to parents and healthcare professionals
We are currently recruiting 30 parents who have experienced a stillbirth to take part in a face-to-face interview to find out what their experiences have been and what impact it has had on their health. Outcomes will be identified by thematic analysis.
As well as informing the next stage of our study to develop a core set of outcomes to improve care after stillbirth, these interviews will also form the basis of a new module on Healthtalk.org. This is a unique website that features video and audio clips from carefully conducted interview studies with patients about experiences of health and illness. There are over 110 conditions already covered and this project will provide an invaluable new information and support resource for bereaved parents, their families and friends about what it is like to experience a stillbirth. Findings will be triangulated with a healthcare professional focus group.
Stage 3: Determining the Core Outcome Set
Parents, doctors, midwives and researchers will participate in a three-round online Delphi study to prioritise outcomes identified in stages 1 & 2. A consensus meeting with stakeholders will be held to determine the COS.
Stage 4: Determining how core outcomes should be measured
An in-depth quality assessment of outcome measurement instruments using consensus based methodology will be take place on short-listed outcomes derived from the Delphi Study.
Patient and public involvement
Patient involvement will be sought throughout the development of the COS. A parent involvement group has been created with 13 parents who have experienced the loss of a baby. Two meetings have so far taken place to inform the research.
Who can participate?
Parents (mothers and/or fathers) who have experienced the loss of a baby in pregnancy after 24 weeks.
What does the study involve?
The time it takes for an interview varies, depending on how much you have to say, but most interviews last at least an hour. The interview will be audio and/or video recorded.
What are the possible benefits and risks of participating?
Developing a core outcome set for care after stillbirth will enable researchers to focus research and clinical care on important outcomes, to make better use of evidence and develop effective interventions for parents experiencing stillbirth.
Given the nature of this study, it is highly unlikely that you will suffer harm by taking part. However, parents find talking about your baby and your experience distressing and upsetting. If this happens you are free to withdraw from the study at any time and we will provide you with contact details for help and support if you wish.
The study started on 2018 and will end 2020
Dr Danya Bakhbakhi
This is funded by an NIHR Doctoral Research Fellowship awarded to Dr Danya Bakhbakhi.
Health Experiences Research Group – University of Oxford
Sands – Stillbirth and Neonatal Death Charity
COMET and CROWN initiatives
National Stillbirth Centre for Research Excellence, Australia
A randomised placebo-controlled trial of mifepristone and misoprostol versus misoprostol alone in the medical management of missed miscarriage
This study will focus on women whose pregnancy sac remains inside the womb (known as a missed miscarriage) and opt for medical management of their miscarriage up to 13+6 weeks of pregnancy. NICE currently recommends that a drug called misoprostol (a vaginal pessary or oral tablet that makes the womb contract) should be used in the medical treatment of miscarriage. However, there is evidence to suggest that combining this drug with mifepristone (an oral tablet that reduces pregnancy hormones) may be more effective in treating miscarriage. Therefore, to test this in a clinical trial, participants will be allocated at random to receive either mifepristone followed by misoprostol, or a dummy drug (placebo) followed by misoprostol. Neither the participants nor the researchers will know what allocation is decided, which is necessary to test the treatments fairly. The main outcome of interest will be whether miscarriage is complete within 7 days of randomisation. If miscarriage is not complete then further treatment (more tablets or surgery) will be offered. A number of other key outcomes, such as the need for an operation, will also be assessed. We will also study the views and experience of the participants regarding the tablet treatment. We anticipate that 710 women will be required to take part in the study to answer this question with confidence. We estimate that we would be able to recruit this many women in two years.
4201 End date: 01/08/2019