Pregnancy specific COVID-19 Studies:
There is currently no known treatment for COVID-19. So far, over 30,000 people are taking part in a range of NIHR supported COVID-19 research studies across the UK.
Nichola Bale, Senior Research Midwife talks about a new Global registry of women aged between 18 and 50 who have had suspected or confirmed Covid-19 in pregnancy and their babies.
The study aims to better understand the effects of corona virus on women and their babies by compiling a global disease registry focussing on birth outcomes.
There is currently no known treatment for Covid-19. So far, over 30,000 people are taking part in a range of NIHR supported COVID-19 research studies across the UK.
Mary Alvarez, Senior Research Midwife, shares with us the UKOSS Covid-19 research study. This is a national UK obstetrics surveillance system for women hospitalised with confirmed Covid-19 in pregnancy. This study will inform ongoing guidance for women and maternity staff as we respond to the pandemic.
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)
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
Contact the Study Team:
Telephone: 0117 414 6764
- Please visit our dedicated webpage for more information. www.nbt.nhs.uk/ASSISTII
Continuous Glucose Monitoring
The Medication Adherence in Pregnancy- Aspirin Study (MAP-A)
Low-dose aspirin prophylaxis is recommended to pregnant women who have risk factors for developing pre-eclampsia. Pre-eclampsia is characterised by high blood pressure and protein in the urine and there is no cure for it except delivery of the baby. Women who have pre-eclampsia can go on to develop serious complications both for themselves and for the baby. Pregnant women are assessed for this risk at the first booking appointment in pregnancy. If they are identified as being at risk they will be recommended to take low-dose aspirin (75-150mg).
We know from talking to women that some find it difficult to, or prefer not to, take the low-dose aspirin that is recommended to them. The aim of the MAP-A study is to find out from women what the barriers and facilitators to taking it are, to inform development of future interventions to support women to take it.
Participants: Pregnant women in the care of NBT who have been recommended low-dose aspirin.
Timeline: July 2020-April 2021
Funder: David Telling Trust
Chief Investigator: Dr Christy Burden
Contact: Dr Anna Davies
Shared Decision Making
The POOL Study
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.
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.
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)