Effectiveness of a maternity improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK)
| ISRCTN | ISRCTN17679951 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17679951 |
| IRAS number | 326510 |
| Secondary identifying numbers | CPMS 57855, IRAS 326510 |
- Submission date
- 24/08/2023
- Registration date
- 30/08/2023
- Last edited
- 30/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
Excess bleeding is the most common complication of childbirth. Every year about 50,000 women in the UK lose 1L (2 pints) of blood or more. Many women develop post-traumatic stress disorder, need blood transfusion or admission to intensive care.
There is a lack of knowledge about how best to treat the excess bleeding.
A care bundle for managing bleeding after birth was developed in Wales and rolled out as a quality improvement programme called the ‘Obstetric Bleeding Strategy’ (OBS). The care bundle has four parts: 1) assessment of each woman’s bleeding risk, 2) accurate measurement of blood loss at all births, 3) a consistent approach to escalation of care to more senior clinicians and 4) bedside tests to identify and treat abnormal blood clotting.
This contrasts with current UK guidelines which recommend measuring blood loss only after excess bleeding is identified. This national study follows on from our pilot study in which we found that the Obstetric Bleeding Strategy care bundle could be successfully adopted by maternity units. The results from this pilot were encouraging, but since this was a small study with limited data, we do not know whether the improvements seen were due to the change in care, or whether the care bundle is value for money. To find this out, this study will compare clinical outcomes, psychological wellbeing and cost of care for women in maternity units that use the care bundle with women receiving standard care.
Who can participate?
We will use routine NHS data on about 189,000 women from 36 NHS maternity units over 30-months. All women giving birth in these units will be included, whether they have excess bleeding or not.
What does the study involve?
All maternity units will start with a period of standard care, they will then adopt the Obstetric Bleeding Strategy care bundle over 9 months, followed by a period of Obstetric Bleeding Strategy care. To measure how effective the Obstetric Bleeding Strategy care bundle is, we will compare rates of blood transfusion before and after it is introduced. We will also study intensive care admission, hysterectomy, breastfeeding rates and various other outcomes. Women with experience of excess bleeding have advised us on the study’s importance, its design, and outcomes. Add-on studies will look at the effect of the Obstetric Bleeding Strategy care bundle on the psychological wellbeing of women and birth partners and how units adopt the care bundle, with special attention to ethnicity and organisational factors. This will include interviewing women, their birth partners and staff to understand their experiences of excess bleeding and whether the Obstetric Bleeding Strategy care bundle changes how teams deliver care. The cost of implementing the bundle and financial impact of having excess bleeding will also be studied. This research will establish whether (and how) the Obstetric Bleeding Strategy care bundle improves outcomes and experiences of women giving birth. We will share our findings widely with the support of UK maternity providers and patient representatives.
What are the possible benefits and risks of participating?
Where is the study run from?
Cardiff University (UK)
When is the study starting and how long is it expected to run for?
May 2023 to January 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Sarah F Bell, OBSUK@cardiff.ac.uk
Contact information
Dr Sarah Bell
Scientific
Scientific
Department of Anaesthetics and Intensive Care
Cardiff and Vale University Health Board
Cardiff
CF14 4XW
United Kingdom
 ORCID ID |
0000-0003-0476-1360 |
|---|---|
| Phone | +44 2920 743107 |
| OBSUK@cardiff.ac.uk |
Study information
| Study design | Stepped wedge cluster randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial |
| Study acronym | OBS UK |
| Study hypothesis | To test the effectiveness of the Obstetric Bleeding Strategy (OBS) intervention compared to standard care on clinical and psychological obstetric bleeding outcomes after childbirth and to evaluate the cost-effectiveness of the OBS intervention compared to standard care. |
| Ethics approval(s) |
Approved 21/09/2023, North West - Greater Manchester Central Research ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 1048 328; gmcentral.rec@hra.nhs.uk), ref: 23/NW/0242 |
| Condition | Obstetric bleeding |
| Intervention | Maternity units will be randomised to one of six sequences, so there will be 6 maternity units in each sequence. Maternity units will initially collect data during a period of standard PPH care for between 3 and 18 months, depending upon the outcome of randomisation. In the first sequence, 6 maternity units will collect standard care data for 3 months. They will then undertake the 9-month implementation period. The second sequence of 6 maternity units will collect standard care data for 6 months. They will then undertake the 9-month implementation period. Subsequent sequences will undertake the implementation period after 9, 12, 15, and 18 months of standard care respectively. Following the 9-month implementation period, maternity units will undertake a period of data collection whilst providing the OBS UK care bundle. This will last between 18 (first sequence) and 3 (last sequence) months depending on the randomisation. OBS UK intervention The OBS UK intervention consists of all three of the following: 1. The OBS UK postpartum haemorrhage (PPH) care bundle 2. Supported by standardised documentation 3. Introduced using quality improvement methods over a 9-month period The OBS UK Care Bundle is ● Assessment of every woman’s bleeding risk ● Quantification of blood loss for all women from the time of birth ● Escalation of multi-professional care to more senior staff at defined volumes of blood loss with appropriate medical intervention ● At 1L blood loss with ongoing bleeding, or earlier for clinical concern, a point-of-care test of haemostasis should be performed and the OBS UK blood component infusion algorithm followed Comparator Standard UK PPH care provided by maternity units prior to implementation of the intervention. Setting The study will take place in 36 NHS maternity units of different sizes and locations, including those serving areas of social deprivation and high proportions of ethnic minority populations. Psychology sub-study: This will study women who experienced PPH >1L and their birth partner’s postnatal mental health (post-traumatic stress and postnatal depression symptoms), acceptability of and satisfaction with the intervention, breastfeeding and adverse effects of the intervention on mother, birth partner (and baby). The outcomes for the psychology sub-study will be collected via questionnaires at 6 weeks (±1 week) and 6 months (±4 weeks) after birth. Health Economic sub-study: This will study cost-effectiveness expressed as incremental cost per confirmed case of red blood cell transfusion avoided and incremental cost per quality-adjusted life year gained over a lifetime horizon. The outcomes for the health economics sub-study will be collected via questionnaires at 6 weeks (±1 week) and 6 months (±4 weeks) after birth from women who experienced PPH >1L and their economic partners. The economic partner may or may not be the same person as the birth partner. In addition, a comparator group of women who did not have a PPH and their partners will complete the economic questionnaires. Process evaluation: A mixed-method approach to understand implementation of the care bundle using quality improvement methodology during the pilot study in Wales (retrospective review) and during the OBS UK trial, exploring how the intervention was deployed and possible improvements to inform wider implementation. Interviews will be carried out with women who have had a PPH and staff who work in maternity units. Observations of training, births and PPH management in maternity units will also take place. Data collection Data will be collected through multiple media including on-line questionnaires for the psychology and economic sub-studies and interviews for the consented process evaluation sub study. For the primary and secondary clinical outcomes data will be collected in following ways: 1. Aggregate data The primary outcome data will be collected in aggregate form from the local sites on a monthly basis. Specifically, each month the site will report to the electronic database how many women have given birth and how many women had a blood transfusion for PPH. This data will be anonymous and will not be at individual level. 2. An anonymised research database will be created to ensure that primary and secondary trial outcomes are due to PPH and allow in-depth analysis of primary and secondary clinical outcomes, demographic and obstetric variables, economic outcomes and process measures to inform interpretation and generalisability of results. This will require linkage of targeted source data with extracts from routinely collected NHS databases. a. Targeted source data Individual, PPH-specific data will be provided by the sites for women who have a PPH of >1.5L and/or receive a blood transfusion for PPH and who have not opted out of sharing data for research use. b. Routinely collected data from NHS databases e.g. HES data Routinely collected data retrieved from NHS databases will provide trial data for all women who have not opted out of the national digital datasets. The psychological and health economic sub-studies will require consent for the completion of online or paper questionnaires. The process evaluation includes ethnographic observations that will not require consent and staff and patient interviews that will require consent. |
| Intervention type | Behavioural |
| Primary outcome measure | Number of women receiving allogenic red blood cell transfusion for PPH from 4 hours before birth until hospital discharge measured using patient records |
| Secondary outcome measures | Clinical outcomes measured using patient records: 1. Blood loss: Total blood loss volume within 4 hours prior to and 24 hours after birth 2. Hysterectomy: Number of women undergoing hysterectomy due to PPH 3. Maternal death: Number of women who died following PPH 4. Higher level of care: Number of women transferred to higher level of care (Level2/3) outside of the obstetric unit for complications following PPH 5. Cardiovascular shock: Number of women transferred to higher level of care outside of the obstetric unit for vasopressor infusion following PPH 6. Organ dysfunction: Number of women transferred to higher level of care outside of the obstetric unit for organ support following PPH 7. Blood transfusion: Number of women transfused cell salvage red blood cells and the volume within 4 hours before birth up until discharge for obstetric bleeding 8. Other blood components/products transfused: Number of women transfused coagulation products including type of product (FFP, cryoprecipitate, platelets or fibrinogen concentrate) and number of units within 4 hours before birth up until discharge for obstetric bleeding 9. Coagulopathy: Number of women with fibrinogen levels <2g/L, ROTEM Fibtem A5 <12mm or TEG CFF MA (by 10 minutes) <17mm, PT/APTT >1.5x midpoint of normal reference range and platelet count <75 x10^9 within 4 hours prior to and 24 hours after birth 10. Haemostatic surgical and radiological interventions: Number of women requiring uterine tamponade balloon insertion, uterine brace suture, transfer to theatre or any radiological intervention for PPH 11. Neonatal death and stillbirth rate: Number of neonatal deaths and stillbirths 12. Length of hospital stay: Time from birth until mother’s discharge 13. Breastfeeding: First feed timing, type, maintenance of breastfeeding including breast milk only at 6 weeks 14. Women and birth partner’s postnatal mental health, women and birth partner’s acceptability of and satisfaction with intervention, breastfeeding and adverse effects of intervention on mother, baby and birth partner: Psychological quantitative study (described below) Psychology outcomes The outcomes for the psychology sub-study will be collected via questionnaires at 6 weeks (±1 week) and 6 months (±4 weeks) after birth 1. Symptoms of depression (mother and birth partner): measured on the Edinburgh Postnatal Depression Score 2. Symptoms of post-traumatic stress disorder (mother and birth partner): measured on the Impact of Events Scale Revised with PPH as a specific event 3. Mother and baby bonding: Mothers’ Object Relations Scale 4. Perspective on whether PPH was psychologically traumatic (mother and birth partner): Diagnostic and Statistical Manual V criterion via a specific criterion question: “You felt you/your birth partner were at risk of death or serious harm”, yes/no 5. Interpersonal factors associated with the experience of childbirth (mother and birth partner): Semantic differential questions co-produced with the study’s patient public involvement group, to capture what was important to them, and their birth partners at the time of their PPH (6 weeks only) 6. Initiation and maintenance of partial/exclusive breastfeeding (mother) 7. Access to professional support or intervention for psychological symptoms related to the birth experience. What, if any, support has been accessed and participant views on this. (mother and birth partner, 6 months only) Cost-effectiveness outcomes The outcomes for the cost-effectiveness analysis (including EQ 5D5L) will be collected via questionnaires at 6 weeks (±1 week) and 6 months (±4 weeks) after birth 1. Incremental cost per confirmed case of allogenic red blood cell transfusion avoided 2. Incremental cost per quality-adjusted life year gained over a lifetime horizon Process evaluation outcomes The outcomes for process evaluation 1. Prospective data from all sites 1.1. Surveys Site context survey at study start and online staff survey at end of the 9-month implementation period 1.2. QI measures 1.2.1. Monthly run charts of PPH volume and RBC transfusion (run charts are displays of time-series data shown in graph form), throughout the implementation and OBS UK periods 1.2.2. Audit and case notes review during implementation (1, 4 and 7 months) 1.2.3. Assessment of sustainability and or decay of components of OBS UK care bundle 1.3. Audit and case notes review at end of study 1.4. Targeted source data Failure to detect a difference between standard and OBS UK care may be due to changes in clinical care which impact on the primary outcome (eg. management of antenatal anaemia and timing of clinical escalation). Therefore haemoglobin and coagulation tests and time of clinical escalation will be collected as process measures for women who experience PPH >1.5L and or receive a blood transfusion due to obstetric bleeding, 2. Case studies Prospective ethnographic and qualitative data collection from six sites (one per sequence) during standard care, implementation and OBS UK care periods and ethnographic and qualitative data collection in four maternity units in Wales where the intervention is embedded into standard care. |
| Overall study start date | 01/05/2023 |
| Overall study end date | 31/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 189,000; UK Sample Size: 189,000 |
| Participant inclusion criteria | Site inclusion criteria: 1. Maternity unit with >2000 births per year 2. Local NHS maternity leaders support the implementation of the OBS UK intervention and quality improvement time for the local champion team. This must include protected midwifery time (4 hours/week) and non-clinical time for consultant obstetrician, anaesthetist, and haematologist from supporting professional activity during the 9-month implementation period For the psychology sub-study inclusion criteria are (requiring individual consent): 1. Women who have experienced a PPH of greater than 1L and their birth partners For the cost-effectiveness sub-study inclusion criteria are (requiring individual consent): 1. Women who have experienced a PPH of greater than 1L and their economic partners 2. Women who have a blood loss of less than 500mL and their economic partners For the process evaluation inclusion criteria are (interviews require individual consent, observation/ethnography study does not require individual consent): 1. Women and, if they would like to be involved, their birth partners who have experienced a PPH of greater than 1 L at one of four maternity units that were included in the pilot study (OBS Cymru) and selected for a site visit 2. Women and, if they would like to be involved, their birth partners who have experienced a PPH of greater than 1L at a maternity unit selected for a process evaluation site visit in the OBS UK study 3. Members of staff at four maternity units that were included in the pilot study (OBS Cymru) and are selected for a site visit 4. Members of the specialist and wider team who work in the maternity service at a maternity unit selected for a process evaluation site visit in the OBS UK study All patients are included in the primary outcome, whilst those opting out will not be included in the datasets/targeted source data. The lower age limit is only for the consenting sub studies. |
| Participant exclusion criteria | Site exclusion criteria: 1. Maternity units that have adopted the entire OBS UK obstetric haemorrhage care bundle 2. Maternity units that use viscoelastic point-of-care tests of haemostasis on the consultant-led delivery suite or in obstetric theatres 3. If a Trust or Health Board has more than one maternity unit then only one can join the study For the psychology sub-study exclusion criteria are (requiring individual consent): 1. Age <16 years, prisoners and individuals who lack capacity 2. Women and birth partners who have had experienced a stillbirth or neonatal death will be excluded from the psychology study component For the cost-effectiveness sub-study exclusion criteria are (requiring individual consent): 1. Age <16 years, prisoners and individuals who lack capacity For the process evaluation exclusion criteria are (interviews require individual consent, observation/ethnography study does not require individual consent): 1. Age <16 years, prisoners and individuals who lack capacity |
| Recruitment start date | 01/02/2024 |
| Recruitment end date | 31/07/2026 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Kings College Hospital
King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
United Kingdom
Denmark Hill
London
SE5 9RS
United Kingdom
James Cook University Hospital
South Tees Hospitals NHS Foundation Trust
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Southampton General Hospital
University of Southampton and University Hospital Southampton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Hampshire Hospitals NHS Foundation Trust
Basingstoke and North Hampshire Hos
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Barts Health NHS Trust
The Royal London Hospital
80 Newark Street
London
E1 2ES
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Blackburn
BB2 3HH
United Kingdom
The Rotherham NHS Foundation Trust
Moorgate Road
Rotherham
S60 2UD
United Kingdom
Rotherham
S60 2UD
United Kingdom
Queen Alexandras Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom
Guildford
GU2 7XX
United Kingdom
NHS Grampian
Summerfield House
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Worcester
WR5 1DD
United Kingdom
Ninewells Hospital
Ninewells Avenue
Dundee
DD1 9SY
United Kingdom
Dundee
DD1 9SY
United Kingdom
Guy's & St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
SE1 7EH
United Kingdom
Milton Keynes University Hospital NHS Foundation Trust
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Homerton Healthcare NHS Foundation Trust
Homerton Row
London
E9 6SR
United Kingdom
London
E9 6SR
United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
Trust Headquarters
Acre Street
Lindley
Huddersfield
HD3 3EA
United Kingdom
Acre Street
Lindley
Huddersfield
HD3 3EA
United Kingdom
St Peters Hospital
Guildford Road
Chertsey
KT16 0PZ
United Kingdom
Chertsey
KT16 0PZ
United Kingdom
Darent Valley Hospital
Darenth Wood Road
Dartford
DA2 8AA
United Kingdom
Dartford
DA2 8AA
United Kingdom
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Wakefield
WF1 4DG
United Kingdom
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Redhill
RH1 5RH
United Kingdom
Northampton General Hospital NHS Trust
Cliftonville
Northampton
NN1 5BD
United Kingdom
Northampton
NN1 5BD
United Kingdom
Warwick Hospital
Lakin Road
Warwick
CV34 5BW
United Kingdom
Warwick
CV34 5BW
United Kingdom
Mid and South Essex NHS Foundation Trust
Prittlewell Chase
Westcliff-on-sea
SS0 0RY
United Kingdom
Westcliff-on-sea
SS0 0RY
United Kingdom
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Sunderland
SR4 7TP
United Kingdom
The Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Maidstone
ME16 9QQ
United Kingdom
Kettering General Hospital NHS Foundation Trust
Rothwell Road
Kettering
NN16 8UZ
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Royal Albert Edward Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom
Wigan
WN1 2NN
United Kingdom
East Sussex Healthcare NHS Trust Hq
St. Annes House
729 the Ridge
St. Leonards-on-sea
TN37 7PT
United Kingdom
729 the Ridge
St. Leonards-on-sea
TN37 7PT
United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Ulster Hospital
Upper Newtownards Rd
Dundonald
Belfast
BT16 1RH
United Kingdom
Dundonald
Belfast
BT16 1RH
United Kingdom
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield Road
Calow
Chesterfield
S44 5BL
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Lanarkshire
Kirklands
Fallside Road
Bothwell
Glasgow
G71 8BB
United Kingdom
Fallside Road
Bothwell
Glasgow
G71 8BB
United Kingdom
Bolton Royal Hospital
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Farnworth
Bolton
BL4 0JR
United Kingdom
Dewi Sant Hospital
Albert Road
Pontypridd
CF37 1LB
United Kingdom
Pontypridd
CF37 1LB
United Kingdom
Cardiff & Vale University Lhb
Woodland House
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Betsi Cadwaladr University Lhb
Executive Offices, Ysbyty Gwynedd
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
The Shrewsbury and Telford Hospital NHS Trust
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Sponsor information
Cardiff University
University/education
University/education
Park Place
Cardiff
CF10 3AT
England
United Kingdom
| Phone | +44 2920 879277 |
|---|---|
| falconerhe@cardiff.ac.uk | |
| Website | http://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC)
No information available
Results and Publications
| Intention to publish date | 31/01/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Targeted source data: Anonymised targeted source data will be available on request and after appropriate approvals from OBSUK@cardiff.ac.uk Linked datasets: we cannot make these available to other researchers due to the requirements of the data provider. However, researchers can apply directly to the organisations responsible, if they wish to access the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | 27/09/2024 | 30/09/2024 | Yes | No |
Editorial Notes
30/09/2024:Publication reference added.
02/04/2024: The participant level data sharing statement was added.
03/10/2023: The ethics approval was added.
24/08/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
