Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655207
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Pivotal Prospective Multi-centre Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients During the Intrapartum Period Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding Including Postpartum Haemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pivotal Prospective Multi-centre Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients During the Intrapartum Period Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding Including Postpartum Haemorrhage in Advance of DeliveryBirth
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
Oli is a predictive non-invasive device intended to be placed on the participants maternal abdomen during the intrapartum period which can alert healthcare professionals of an impending cumulative blood loss of 500 ml abnormal postpartum uterine bleeding or cumulative blood loss of 1000ml postpartum haemorrhage at least 1 hour in advance of birth This study is being undertaken to assess the performance of Oli measuring cumulative blood loss 500ml and 1000ml as well as evaluate its safety profile
Detailed Description:
None
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