Defining, Recognising and Escalating Maternal Early Deterioration (DREaMED): Decreasing Inequality Through Improved Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 459,160
- 试验地点
- 1
- 主要终点
- To develop, and validate an electronically-embedded, data-enhanced Maternal Early Warning Score (eMOEWS) with clinical escalation pathways
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women aged 16 or over who are pregnant
- •At any of the study sites
排除标准
- •Patients who have requested that their data not be used for research (e.g., NHS Opt-out).
- •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
结局指标
主要结局
To develop, and validate an electronically-embedded, data-enhanced Maternal Early Warning Score (eMOEWS) with clinical escalation pathways
时间窗: During pregnancy or in the immediate postpartum period.
Predictive performance of new early warning scores, assessed by: discrimination, calibration, and clinical utility.
次要结局
- 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 and validate an optimal vital-signs-only-based MOEWS(05/2029)
- 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 eMOEWS to improve detection in comparison to existing MOEWS/MEWS(05/2029)
- To design and deliver an eMOEWS interface(05/2029)
- To develop treatment escalation pathways(05/2029)