Clinical trial NCT06916832: Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage
Official title: Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delivery Hemorrhage
Keywords: Delivery hemorrhage
Pregnancy
Blood transfusion
Patient blood management
Iron supplementation
Gestational anemia
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who suffered a delivery hemorrhage during childbirth,in the maternity ward of Hôpital Sainte Musse

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: RGC transfusion rate
timeFrame: 24 hours postpartum
Secondary outcomes:
measure: Number of RGCs transfused during the first 24 hours postpartum
timeFrame: 24 hours postpartum
measure: Prescription of intra-venous iron during pregnancy
timeFrame: 24 hours postpartum
measure: Hemoglobin level at hospital discharge
timeFrame: Day 7 postpartum
measure: Treatments for the management of delivery haemorrhage.
timeFrame: Day 7 postpartum
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon-La Seyne sur mer
state: VAR
Study officials:
affiliation: Centre Intercommunal Toulon-La Seyne sur Mer
name: Géraldine SLEHOHER-LHERIAU, MD
role: STUDY_DIRECTOR
References: