Pregnancy ComplicationsDREaMEDNCT06560931
Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED)
An observational study of Pregnancy Complications and Pregnancy, High Risk, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Every year more than 700,000 women give birth in the United Kingdom. Of these at least 8700 nearly die - called a "near-miss", and 70 die. Many more women suffer harm, often with effects lasting for life. Women from less wealthy areas and particular ethnic groups are more likely to come to harm. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Pregnancy, High Risk
- How many people
- 459,160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2023to 1 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patient retrospective and prospective data: All women who are treated by maternity services at study sites. MBRRACE-UK cohort: All cases of maternal death and morbidity (for the cohorts described above) collected by MBRRACE-UK Patient interviews/Focus groups(escalation pathway): Women and their partners who have experienced near-miss events or other maternal complications. Staff interviews/focus groups (escalation pathway and eMOEWS interface development): Staff members will be involved in focus groups, interviews and testing the eMOEWS user interface. Staff training (simulation scenarios): Staff will also take part in scenario simulations (MOET).
Who may be able to join
- All women aged 16 or over who are pregnant
- At any of the study sites
- Staff members aged 16 or over in a partner hospital.
- Involved in the care, management and escalation of hospitalised women who deteriorate in maternity services.
Who cannot join
- Patients who have requested that their data not be used for research (e.g., NHS Opt-out).
- Staff:
- Staff who do not consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED): Decreasing Inequality Through Improved Outcomes.
Every year more than 700,000 women give birth in the United Kingdom. Of these at least 8700 nearly die - called a "near-miss", and 70 die. Many more women suffer harm, often with effects lasting for life. Women from less wealthy areas and particular ethnic groups are more likely to come to harm.
"Vital signs" include measurements of blood pressure, heart and breathing rates. Doctors and midwives use tools that score vital signs to spot women becoming unwell. These tools are called "Modified Obstetric Early Warning Scores" (MOEWS). Despite their use, poor outcomes still occur. This may be because MOEWS use only the most recent vital signs. Using extra data like blood tests may help spot unwell people earlier.
Read more
The study aims to reduce poor outcomes for women giving birth. The study will find better ways of describing, spotting, and treating women becoming unwell.
The study have planned four linked projects to develop an electronic advanced maternal obstetric early warning system (eMOEWS). Patient and Public (PPIE) collaborators have developed this work with CI's. The study work closely with them throughout this project.
Once the study has completed these four projects, they plan to carry out a trial to assess whether the new eMOEWS leads to better outcomes than the existing tools.
Read the detailed description
Every year more than 700,000 women give birth in the United Kingdom. Of these at least 8700 nearly die - called a "near-miss", and 70 die. Many more women suffer harm, often with effects lasting for life. Women from less wealthy areas and particular ethnic groups are more likely to come to harm.
"Vital signs" include measurements of blood pressure, heart and breathing rates. Doctors and midwives use tools that score vital signs to spot women becoming unwell. These tools are called "Modified Obstetric Early Warning Scores" (MOEWS). Despite their use, poor outcomes still occur. This may be because MOEWS use only the most recent vital signs. Using extra data like blood tests may help spot unwell people earlier.
The study aims to reduce poor outcomes for women giving birth. The study will find better ways of describing, spotting, and treating women becoming unwell.
The study has planned four linked projects to develop an electronic advanced maternal obstetric early warning system (eMOEWS). Patient and Public (PPIE) collaborators have developed this work with the CI's. The study will work closely with them throughout this project.
Once the study have completed these four projects, they plan to carry out a trial to assess whether the new eMOEWS leads to better outcomes than the existing tools. This trial will be described in a separate protocol.
Project One The study will develop new definitions of worsening illness in women giving birth. They will work with the PPIE colleagues and other experts, reviewing published work. This will help staff use routinely collected health data to spot early illness, before a woman becomes very unwell. The study will check that the new definitions reliably identify women becoming unwell.
Project Two Using the new definitions, the study will test how well current MOEWS pick up worsening illness. The study will use data from eight to twelve NHS maternity units serving diverse women, and our national maternal review programme.
Project Three The study will develop an advanced, electronic MOEWS (eMOEWS) working with our PPIE collaborators and other experts. This will use extra information known to affect the risk of poor outcomes. The study will test how well the eMOEWS spots worsening illness, using our new definitions.
Project Four The study will develop a way to digitally display eMOEWS on maternity units. The study will work with staff who use computers along with experts in NHS computer systems. This will allow staff to understand quickly which women are at risk, and why. The study will design guidelines for how to use eMOEWS on maternity units with women and staff. This will make sure our new system helps give women the right care at the right time.
- Conditions
- Pregnancy Complications, Pregnancy, High Risk
- Keywords
- Pregnancy Complications, Pregnancy, High Risk, Near-miss
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | This study consists of a programme of work that is centred around a UK-based, multi-centre cohort study of women who are pregnant or have recently been pregnant. The study will use retrospective data from three representative collaborator NHS hospitals (who will form part of the retrospective cohort). | |
| Prospective cohort | This study consists of a programme of work that is centred around a UK-based, multi-centre cohort study of women who are pregnant or have recently been pregnant. | |
| MBRRACE-UK cohort | The study will use data from MBRRACE-UK, reviewing deaths, near-miss and pre-near-miss cases to estimate identification performance using the new definitions. | |
| Patient interviews (escalation pathway) | This study consists of a programme of work that is centred around a UK-based, multi-centre cohort study of women who are pregnant or have recently been pregnant. All women in the cohort are likely to have had one of the near-miss or pre-near-miss events (as defined in WS1) or death. | |
| Staff interviews/focus groups (escalation pathway) | Staff members will be involved in focus groups, interviews and testing the eMOEWS user interface. Inclusion criteria * Staff members aged 16 or over in a partner hospital. * Involved in the care, management and escalation of hospitalised women who deteriorate in maternity services. | |
| Staff interviews/focus groups (eMOEWS interface development) | Staff members will be involved in focus groups, interviews and testing the eMOEWS user interface. Inclusion criteria * Staff members aged 16 or over in a partner hospital. * Involved in the care, management and escalation of hospitalised women who deteriorate in maternity services. | |
| Staff training (simulation scenarios) | Staff will also take part in scenario simulations (MOET). Inclusion criteria * Staff members aged 16 or over in a partner hospital. * Involved in the care, management and escalation of hospitalised women who deteriorate in maternity services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop, and validate an electronically-embedded, data-enhanced Maternal Early Warning Score (eMOEWS) with clinical escalation pathways
Predictive performance of new early warning scores, assessed by: discrimination, calibration, and clinical utility.
Measured: During pregnancy or in the immediate postpartum period.
Secondary outcomes (8)
To define 'near-miss' and 'pre-near-miss' criteria for use with routinely-collected data to measure maternal outcomes
'Near-miss' and 'pre-near-miss' outcome criteria measurable using routinely available electronic data, assessed in NHS hospitals
Measured: During pregnancy or in the immediate postpartum period.
To assess performance of the new near-miss and pre-near-miss outcome criteria in 3 hospitals and MBRRACE-UK.
Descriptive statistics to describe whether the electronic criteria used correctly identified the conditions.
Descriptive statistics of missed and captured events according to electronic criteria Descriptive comparison to published rates
Measured: During pregnancy or in the immediate postpartum period.
To develop a large representative eight to twelve maternity unit cohort for model development and assessment
Cohort developed and ready for assessment
Measured: 05/2029
To investigate the performance of existing MOEWS/MEWS in the new maternity cohort and in women who have died or had a near-miss or pre-near-miss event in pregnancy
Evidence-based assessment of existing MOEWS, both in new retrospective (assessed by discrimination, risk of our key events at each MOEWS/MEWS level) and nationally recognised mortality/morbidity (assessed by sensitivity and duration of prior warning) cohorts
Measured: 05/2029
To develop and validate an optimal vital-signs-only-based MOEWS
Relative performance of new MOEWS, best published MOEWS and NHSI national MOEWS for prediction of near-miss or pre-near-miss
Measured: 05/2029
To develop and validate an eMOEWS to improve detection in comparison to existing MOEWS/MEWS
Relative performance assessment of eMOEWS, new validated vital-signs-based MOEWS, best published MOEWS and NHSI national MOEWS for prediction of 'near-miss' or 'pre-near-miss'
Measured: 05/2029
To design and deliver an eMOEWS interface
User co-designed eMOEWS implemented within 4 NHS sites. System Usability Scale performance
Measured: 05/2029
To develop treatment escalation pathways
Escalation and response pathways protocolised iterated and tested in a simulated environment
Measured: 05/2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start2 May 2023
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 459,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- NHS England, Guy's and St Thomas' NHS Foundation Trust, King's College London
- Responsible party
- Sponsor
- Investigators
- Peter Watkinson, Principal investigator, University of OxfordMarian Knight, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560931
- Sponsor's protocol ID
- PID17763
- Acronym
- DREaMED
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED): Decreasing Inequality Through Improved Outcomes.
- ClinicalTrials.gov ID
- NCT06560931
- Acronym / sponsor ID
- DREaMED / PID17763
- Conditions
- Pregnancy Complications, Pregnancy, High Risk
- Keywords
- Pregnancy Complications, Pregnancy, High Risk, Near-miss
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 459,160 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- NHS England, Guy's and St Thomas' NHS Foundation Trust, King's College London
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Every year more than 700,000 women give birth in the United Kingdom. Of these at least 8700 nearly die - called a "near-miss", and 70 die. Many more women suffer harm, often with effects lasting for life. Women from less wealthy areas and particular ethnic groups are more likely to come to harm.
"Vital signs" include measurements of blood pressure, heart and breathing rates. Doctors and midwives use tools that score vital signs to spot women becoming unwell. These tools are called "Modified Obstetric Early Warning Scores" (MOEWS). Despite their use, poor outcomes still occur. This may be because MOEWS use only the most recent vital signs. Using extra data like blood tests may help spot unwell people earlier.
The study aims to reduce poor outcomes for women giving birth. The study will find better ways of describing, spotting, and treating women becoming unwell.
The study have planned four linked projects to develop an electronic advanced maternal obstetric early warning system (eMOEWS). Patient and Public (PPIE) collaborators have developed this work with CI's. The study work closely with them throughout this project.
Once the study has completed these four projects, they plan to carry out a trial to assess whether the new eMOEWS leads to better outcomes than the existing tools.
Detailed description
Every year more than 700,000 women give birth in the United Kingdom. Of these at least 8700 nearly die - called a "near-miss", and 70 die. Many more women suffer harm, often with effects lasting for life. Women from less wealthy areas and particular ethnic groups are more likely to come to harm.
"Vital signs" include measurements of blood pressure, heart and breathing rates. Doctors and midwives use tools that score vital signs to spot women becoming unwell. These tools are called "Modified Obstetric Early Warning Scores" (MOEWS). Despite their use, poor outcomes still occur. This may be because MOEWS use only the most recent vital signs. Using extra data like blood tests may help spot unwell people earlier.
The study aims to reduce poor outcomes for women giving birth. The study will find better ways of describing, spotting, and treating women becoming unwell.
The study has planned four linked projects to develop an electronic advanced maternal obstetric early warning system (eMOEWS). Patient and Public (PPIE) collaborators have developed this work with the CI's. The study will work closely with them throughout this project.
Once the study have completed these four projects, they plan to carry out a trial to assess whether the new eMOEWS leads to better outcomes than the existing tools. This trial will be described in a separate protocol.
Project One The study will develop new definitions of worsening illness in women giving birth. They will work with the PPIE colleagues and other experts, reviewing published work. This will help staff use routinely collected health data to spot early illness, before a woman becomes very unwell. The study will check that the new definitions reliably identify women becoming unwell.
Project Two Using the new definitions, the study will test how well current MOEWS pick up worsening illness. The study will use data from eight to twelve NHS maternity units serving diverse women, and our national maternal review programme.
Project Three The study will develop an advanced, electronic MOEWS (eMOEWS) working with our PPIE collaborators and other experts. This will use extra information known to affect the risk of poor outcomes. The study will test how well the eMOEWS spots worsening illness, using our new definitions.
Project Four The study will develop a way to digitally display eMOEWS on maternity units. The study will work with staff who use computers along with experts in NHS computer systems. This will allow staff to understand quickly which women are at risk, and why. The study will design guidelines for how to use eMOEWS on maternity units with women and staff. This will make sure our new system helps give women the right care at the right time.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –This study consists of a programme of work that is centred around a UK-based, multi-centre cohort study of women who are pregnant or have recently been pregnant. The study will use retrospective data from three representative collaborator NHS hospitals (who will form part of the retrospective cohort). |
| Prospective cohort | – | –This study consists of a programme of work that is centred around a UK-based, multi-centre cohort study of women who are pregnant or have recently been pregnant. |
| MBRRACE-UK cohort | – | –The study will use data from MBRRACE-UK, reviewing deaths, near-miss and pre-near-miss cases to estimate identification performance using the new definitions. |
| Patient interviews (escalation pathway) | – | –This study consists of a programme of work that is centred around a UK-based, multi-centre cohort study of women who are pregnant or have recently been pregnant. All women in the cohort are likely to have had one of the near-miss or pre-near-miss events (as defined in WS1) or death. |
| Staff interviews/focus groups (escalation pathway) | – | –Staff members will be involved in focus groups, interviews and testing the eMOEWS user interface. Inclusion criteria * Staff members aged 16 or over in a partner hospital. * Involved in the care, management and escalation of hospitalised women who deteriorate in maternity services. |
| Staff interviews/focus groups (eMOEWS interface development) | – | –Staff members will be involved in focus groups, interviews and testing the eMOEWS user interface. Inclusion criteria * Staff members aged 16 or over in a partner hospital. * Involved in the care, management and escalation of hospitalised women who deteriorate in maternity services. |
| Staff training (simulation scenarios) | – | –Staff will also take part in scenario simulations (MOET). Inclusion criteria * Staff members aged 16 or over in a partner hospital. * Involved in the care, management and escalation of hospitalised women who deteriorate in maternity services. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient retrospective and prospective data: All women who are treated by maternity services at study sites. MBRRACE-UK cohort: All cases of maternal death and morbidity (for the cohorts described above) collected by MBRRACE-UK Patient interviews/Focus groups(escalation pathway): Women and their partners who have experienced near-miss events or other maternal complications. Staff interviews/focus groups (escalation pathway and eMOEWS interface development): Staff members will be involved in focus groups, interviews and testing the eMOEWS user interface. Staff training (simulation scenarios): Staff will also take part in scenario simulations (MOET).
Key inclusion criteria (4 listed)
- All women aged 16 or over who are pregnant
- At any of the study sites
- Staff members aged 16 or over in a partner hospital.
- Involved in the care, management and escalation of hospitalised women who deteriorate in maternity services.
Key exclusion criteria (3 listed)
- Patients who have requested that their data not be used for research (e.g., NHS Opt-out).
- Staff who do not consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To develop, and validate an electronically-embedded, data-enhanced Maternal Early Warning Score (eMOEWS) with clinical escalation pathways
Time frame: During pregnancy or in the immediate postpartum period.
Predictive performance of new early warning scores, assessed by: discrimination, calibration, and clinical utility.
8 secondary outcomes
To define 'near-miss' and 'pre-near-miss' criteria for use with routinely-collected data to measure maternal outcomes
Time frame: During pregnancy or in the immediate postpartum period.
To assess performance of the new near-miss and pre-near-miss outcome criteria in 3 hospitals and MBRRACE-UK.
Time frame: During pregnancy or in the immediate postpartum period.
To develop a large representative eight to twelve maternity unit cohort for model development and assessment
Time frame: 05/2029
To investigate the performance of existing MOEWS/MEWS in the new maternity cohort and in women who have died or had a near-miss or pre-near-miss event in pregnancy
Time frame: 05/2029
To develop and validate an optimal vital-signs-only-based MOEWS
Time frame: 05/2029
To develop and validate an eMOEWS to improve detection in comparison to existing MOEWS/MEWS
Time frame: 05/2029
To design and deliver an eMOEWS interface
Time frame: 05/2029
To develop treatment escalation pathways
Time frame: 05/2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Watkinson principal investigator
University of Oxford
Marian Knight principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Pregnancy, High Risk, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop, and validate an electronically-embedded, data-enhanced Maternal Early Warning Score (eMOEWS) with clinical escalation pathways (time frame: During pregnancy or in the immediate postpartum period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.