Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED)
NCT Number: NCT06560931
Acronym: DREaMED
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy Complications|Pregnancy, High Risk
Sponsor: University of Oxford
Collaborators: NHS England|Guy's and St Thomas' NHS Foundation Trust|King's College London
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 459160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-02
Completion Date: 2029-05-01
Locations: Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, Oxfordshire, OX3 9DU, United Kingdom

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.

Primary Outcome Measures: 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., During pregnancy or in the immediate postpartum period.
Secondary Outcome Measures: 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, 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, 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, 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, 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, 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', 05/2029|To design and deliver an eMOEWS interface, User co-designed eMOEWS implemented within 4 NHS sites. System Usability Scale performance, 05/2029|To develop treatment escalation pathways, Escalation and response pathways protocolised iterated and tested in a simulated environment, 05/2029