Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED)

NCT06560931 | Active Not Recruiting

• 1 other identifier: PID17763
• Study Type: observational
• Target: 459,160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications; Pregnancy, High Risk

Keywords

Pregnancy Complications; Pregnancy, High Risk; Near-miss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• To define 'near-miss' and 'pre-near-miss' criteria for use with routinely-collected data to measure maternal outcomes

  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.

  During pregnancy or in the immediate postpartum period.

• To develop a large representative eight to twelve maternity unit cohort for model development and 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

  05/2029

• To develop and validate an optimal vital-signs-only-based MOEWS

  05/2029

Study Arms (7)

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.

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: All women aged 16 or over who are pregnant
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead
• NHS England: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• King's College London: collaborator

Study Sites (1)

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

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Peter Watkinson

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Marian Knight

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: May 2, 2023
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)