Clinical trial NCT06560931: Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED)
Official title: Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED): Decreasing Inequality Through Improved Outcomes.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnancy Complications
Pregnancy, High Risk
Keywords: Pregnancy Complications
Pregnancy, High Risk
Near-miss
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: NHS England
name: Guy's and St Thomas' NHS Foundation Trust
name: King's College London
First posted: 2024-08-19
Enrollment: 459160
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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.

"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.

Eligibility criteria: Patient data collection:

Inclusion Criteria:

* All women aged 16 or over who are pregnant
* At any of the study sites

Exclusion Criteria:

• Patients who have requested that their data not be used for research (e.g., NHS Opt-out).

Staff:

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.

Exclusion criteria

• Staff who do not consent

Primary outcomes:
measure: To develop, and validate an electronically-embedded, data-enhanced Maternal Early Warning Score (eMOEWS) with clinical escalation pathways
timeFrame: During pregnancy or in the immediate postpartum period.
Secondary outcomes:
measure: To define 'near-miss' and 'pre-near-miss' criteria for use with routinely-collected data to measure maternal outcomes
timeFrame: During pregnancy or in the immediate postpartum period.
measure: To assess performance of the new near-miss and pre-near-miss outcome criteria in 3 hospitals and MBRRACE-UK.
timeFrame: During pregnancy or in the immediate postpartum period.
measure: To develop a large representative eight to twelve maternity unit cohort for model development and assessment
timeFrame: 05/2029
measure: 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
timeFrame: 05/2029
measure: To develop and validate an optimal vital-signs-only-based MOEWS
timeFrame: 05/2029
measure: To develop and validate an eMOEWS to improve detection in comparison to existing MOEWS/MEWS
timeFrame: 05/2029
measure: To design and deliver an eMOEWS interface
timeFrame: 05/2029
measure: To develop treatment escalation pathways
timeFrame: 05/2029
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Peter Watkinson
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Marian Knight
role: PRINCIPAL_INVESTIGATOR
References: