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.

ACE

Antenatal Care Education: the co-design and piloting of interventions to improve patient and staff experience through better birth preparedness.

Study Summary:

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.

Study Timeline
The study started on 01st January 2019 and will end on 31st March 2020.

Further details
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 (abi.merriel@bristol.ac.uk)

AKID

Acute Kidney Injury and Gestational Diabetes in pregnancy – A prospective cohort study.

The aim of this study is to help better understand kidney function throughout pregnancy and blood sugar (glucose) levels late in pregnancy.
Acute Kidney Injury(AKI) is a sudden fall in kidney function. It can happen in pregnancy, during birth and after birth. AKI can cause problems for the pregnancy and the mother and in the longer term for a mother’s health. Currently, normal kidney function in pregnancy is unknown. This study will aim to more clearly define normal kidney function levels in pregnancy, thereby allowing a more accurate diagnosis of Acute Kidney Injury in the future.
Gestational diabetes is a type of diabetes that can develop during  pregnancy. Currently, gestational diabetes is diagnosed by a test called an Oral Glucose Tolerance TEST (OGTT), which is performed at around 24-28 weeks of pregnancy and is offered to mother’s who have risk factors for developing gestational diabetes. At times, whilst this result is normal, some women may go on to develop late onset of gestational diabetes and it may go undetected.     

This study aims to look at normal levels of glucose in pregnant women after 32 weeks of pregnancy, using 2 types of test, with a view of finding best way to diagnose late onset gestational diabetes.
Women can choose to take part in both parts of the study, or the AKI aspect of the study.
The study commenced December 2019

ASSIST II

Around one in eight women in the UK require assistance to give birth to their baby vaginally. Currently, doctors use either forceps or a ventouse (a suction cup) to help women have their babies in this manner. This is known as an assisted vaginal birth (AVB). Most mothers and babies do very well after an AVB, and the procedure is usually much better for both mothers and babies than the alternative, an emergency Caesarean section.

ASSIST logo
However, women and their babies can sometimes be harmed by an AVB. Mothers have a greater tendency to have severe tears of the vagina, and, sometimes, the rectum (back passage) compared to a spontaneous vaginal birth. Mothers may have more pain while healing (usually for one to two weeks) following a birth that has been assisted by forceps or ventouse. Babies may develop bruising over the scalp or face where the forceps or ventouse have been applied. Babies can also, very rarely (around 1 in 1000), sustain more serious harm, such as nerve injuries or bleeding into the brain or eye. Therefore, although AVB is generally very safe and usually better than the alternative (an emergency caesarean section), it is sensible to try to improve the technique to assist a vaginal birth and reduce the risks to both mothers and their babies. Unfortunately, no new types of devices to assist vaginal birth have been introduced into practice since the ventouse in the 1950s.
The BD Odon Device is a new device for AVB that has been designed by a team of midwives, doctors and engineers. The BD Odon Device works by placing a cuff of air which is attached to a sleeve, around the baby’s head. The doctor then gently pulls on this sleeve and air cuff to assist the birth of the baby.

Following on from the ASSIST Study which was conducted between October 2018 and January 2019, ASSIST II is a second intrapartum study in which we would like to use the BD Odon Device to help women give birth in cases where it is necessary to assist the birth of their baby. Our study will evaluate the safety and effectiveness of the BD Odon device and seek the views of women and healthcare professionals on its use. The information gained from the study will be used to plan a large comparative study.
 

BRIST-IVF

The Bristol IVF Study has been set up to investigate the success of IVF treatment.
Led by Professor Debbie Lawlor and Dr Amy Taylor at the University of Bristol and Dr Valentine Akande at the BCRM.
We are recruiting women, and their partners, undergoing IVF treatment. We are inviting individuals/couples who become pregnant, following IVF treatment, to attend pregnancy clinics at the University of Bristol. This will help to understand more about the impact of IVF treatment on short and longer term outcomes.
We recruited our first couple to the study in September 2019.

CHANCE

CHronic endometritis ANd unexplained reCurrent misscarriagE: the role of the endometrial microbiome

Study Summary:

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.
Study Timeline
The study started on 01st April 2019 and will end on 31st March 2021.

Further details
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 (i.gamaleldin@bristol.ac.uk)

GEM3

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.

4462
End date: 30/04/2019

iCHOOSE

Development of a core outcome set and identification of outcome measurement tools to improve care and research for care after stillbirth. 

Aims

To develop a Core Outcome Set (COS) and identify outcome measurement tools to improve care and research after stillbirth.

Background 

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.

Methods

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. 

IF OPEN:

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.  

Study Timeline
The study started on 2018 and will end 2020

Study Contact
Dr Danya Bakhbakhi
Ichoose-research@bristol.ac.uk

Further details
This is funded by an NIHR Doctoral Research Fellowship awarded to Dr Danya Bakhbakhi.
Collaborators include:
Health Experiences Research Group – University of Oxford
Sands – Stillbirth and Neonatal Death Charity
COMET and CROWN initiatives
National Stillbirth Centre for Research Excellence, Australia

Pool

The pool study is a data collection study with the aim of answering the question about the safety of waterbirths.
Information is collected via the hospital’s maternity electronic information system form all women who labour or give birth in water until December 2020, unless a woman specifically opts out of having this data collected.

The study will determine
• How  many women are using birth pools
• How many women give birth in water
• Whether mothers and their babies come to any extra harm as a result of waterbirth.
For babies that need specialist care after their birth, the study will also use the data held by the National Neonatal Research Database(NNRD)
All women who use a pool as part of their labour or birth will be given an information card about the study and they can let the midwife providing their care if they wish to opt out from this study.
For more information about the study: https://www.cardiff.ac.uk/centre-for-trials-research/research/studies-an...

Stich

Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes (C-STICH)

The C-STICH study is a multi-centre Randomised Controlled Trial involving women who are deemed to be at risk of an insufficient cervix, whereby the cervix begins to shorten (efface) and open (dilate).  This can contribute to premature labour and birth, as well as pregnancy loss. One of the treatments offered for this is a scheduled cervical cerclage, whereby a doctor will place a stitch within the cervix (neck of the womb) to help to keep it closed. This does not guarantee to keep the cervix closed, but can allow the pregnancy to continue for a few more weeks. The stitch is scheduled to be removed as the pregnancy reaches near term, usually around 36- 38 weeks gestation.
C-STICH study is investigating the effects of using either a smooth or a braided fibre suture as the stitch choice. Currently, both types are in use in clinical practice, with no consensus as to which gives better pregnancy outcomes.
The study is aiming to recruit 2050 patients by June 2020.

The Pancovid Study

A Covid-19 research study for women who may have been symptomatic whilst pregnant.
This study aims to collect information about COVID-19 and SARS-CoV-2 in pregnancy and babies from around the world into a register which the research team will use to share information with healthcare professionals around the world, allowing them to improve the care they give.
view or download the study information sheet.  PDF icon PAN-COVID PIS v5.1_16042020.pdf