Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-01 @ 4:54 PM
Study NCT ID:
NCT06916832
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage
Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Organization:
Study Overview
Official Title:
Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALOMA
Brief Summary:
According to the WHO, anemia is one of the ten most serious health problems in the world. During pregnancy, it affects 42% of women worldwide and 25% in France. It is associated with an increased risk of perinatal morbidity and mortality, and recourse to blood transfusion. The blood transfusion is itself also a source of thromboembolic morbidity and mortality, infectious diseases and pulmonary pathologies. In addition, the risk of hemorrhage, particularly during delivery, is inherent to all pregnancies and difficult to predict.
Since 2010, the WHO has defined the rational use of blood products as the 4th global priority, and the need for countries to reduce blood transfusion. It introduces the concept of Patient Blood Management (PBM). This is a set of measures designed to manage anemia and bleeding in surgical patients, while avoiding the need for transfusion. These measures include preoperative screening for anemia and martial deficiency, iron and vitamin supplementation, intraoperative bleeding control and optimization of postoperative blood balance. Recommended by several national programs, PBM has developed rapidly in orthopedic and cardiac surgery, where numerous studies have demonstrated its effectiveness, particularly in terms of transfusion savings. In obstetrics, however, the implementation of PBM remains less widespread, notably due to the difficulty of getting teams on board, and the absence of protocolization.
However, given the high prevalence of anemia in pregnant women, and the inherent risk of hemorrhage in all deliveries with potential recourse to blood transfusion, personalized optimization of PBM is a major challenge in obstetrics.
The PBM is currently being implemented in routine practice in the CHITS maternity department, in line with recommendations.
In this context, our research aims to assess the impact of this new approach. Our main hypothesis is that implementation of a PBM protocol would reduce the rate of transfusion in delivery hemorrhage.
Since 2010, the WHO has defined the rational use of blood products as the 4th global priority, and the need for countries to reduce blood transfusion. It introduces the concept of Patient Blood Management (PBM). This is a set of measures designed to manage anemia and bleeding in surgical patients, while avoiding the need for transfusion. These measures include preoperative screening for anemia and martial deficiency, iron and vitamin supplementation, intraoperative bleeding control and optimization of postoperative blood balance. Recommended by several national programs, PBM has developed rapidly in orthopedic and cardiac surgery, where numerous studies have demonstrated its effectiveness, particularly in terms of transfusion savings. In obstetrics, however, the implementation of PBM remains less widespread, notably due to the difficulty of getting teams on board, and the absence of protocolization.
However, given the high prevalence of anemia in pregnant women, and the inherent risk of hemorrhage in all deliveries with potential recourse to blood transfusion, personalized optimization of PBM is a major challenge in obstetrics.
The PBM is currently being implemented in routine practice in the CHITS maternity department, in line with recommendations.
In this context, our research aims to assess the impact of this new approach. Our main hypothesis is that implementation of a PBM protocol would reduce the rate of transfusion in delivery hemorrhage.
Detailed Description:
From 1 January 2023 to 31 December 2025, the investigators conducted a single-center, before-and-after study at the maternity unit of the Sainte Musse hospital in Toulon (level IIB maternity unit). This is a retrospective observational study with a retrospective section covering the period before the implementation of the PBM protocol between 1 January 2023 and 31 December 2024. Then a prospective part covering the period after the implementation of the PBM protocol, from 1 January 2025 to 31 December 2025.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: