WCH Research Unit Current Studies

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)

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

ASSIST

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.
In this study, 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 the 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

MifeMiso

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