Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED) (DREaMED)

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Complications; Pregnancy, High Risk

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 Type: Observational
• Enrollment (Estimated): 459160

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: King's College London; Guy's and St Thomas' NHS Foundation Trust; NHS England
• Investigators: Principal Investigator: Peter Watkinson, University of Oxford; Principal Investigator: Marian Knight, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy Complications; Pregnancy, High Risk; Near-miss
• Additional Relevant MeSH Terms: Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications
• Other Study ID Numbers: PID17763

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No