Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage (PALOMA)

Intermunicipal Hospital Center Toulon

Status: Enrolling

Conditions: Delivery Hemorrhage

Study type: Observational

Funder types: Other

Identifiers

NCT06916832

2024-CHITS-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient who has had a delivery hemorrhage, whatever the mode of delivery

Exclusion criteria

• Minor
• Under legal protection
• Hemoglobinopathies
• Patient's refusal to participate in research

Trial design

240 participants in 2 patient groups

Before protocol implementation

Description:

pregnant women who did not use the patient blood management protocol during their pregnancy. In other words, women who gave birth in 2023 and 2024.

After protocol implementation

Description:

pregnant women who benefited from the patient blood management protocol during their pregnancy. In other words, women who gave birth in 2025.