Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560931
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Defining Recognising and Escalating Maternal Early Deterioration DREaMED
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Defining Recognising and Escalating Maternal Early Deterioration DREaMED Decreasing Inequality Through Improved Outcomes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREaMED
Brief Summary:
Every year more than 700000 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 CIs 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
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 CIs 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 700000 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 CIs 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
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 CIs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None