Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED)

NCT ID: NCT06560931

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 459160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2029-05-01

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.

Conditions

Pregnancy Complications; Pregnancy, High Risk

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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).

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

Staff:

• Staff who do not consent

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NHS England

OTHER_GOV

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Watkinson

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Marian Knight

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PID17763

Identifier Type: -

Identifier Source: org_study_id